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FDA OKs new weight-loss pill
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WASHINGTON (AP) - The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.
Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.
The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol. The drug should be used in combination with a healthy diet and exercise.
Obesity Society President Patrick O'Neil said he's encouraged by the drug's approval because it underscores the notion that lifestyle changes alone are not enough to treat obesity.
"This is good news because it tells us that the FDA is indeed treating obesity seriously," said O'Neil, who teaches at Medical University of South Carolina and was the lead researcher on several studies of Belviq. "On the other hand, it's not the answer to the problem or even a big part of the answer."
Even if the effects of Belviq are subtle, experts say it could be an important first step in developing new treatments that attack the underlying causes of obesity.
"The way these things tend to work is you have some people who do extremely well and other people don't lose any weight at all. But if we had 10 medicines that were all different and worked like this, we would have a real field," said Dr. Louis Aronne, director of the weight loss program at Weill-Cornell Medical College.
The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.
Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.
With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments.
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FDA OKs new weight-loss pill
Dr. Manny: New FDA approved anti-obesity pill no 'silver bullet'
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The Food and Drug Administration (FDA) approved Arena Pharmaceuticals anti-obesity pill Belviq Wednesday, making it the first federal-approved prescription drug intended to stimulate long-term weight loss in 13 years. The drug is expected to enter the U.S. market within the next decade.
Belviq was originally denied approval in 2010 over concerns that it might cause tumors, but Arena resubmitted its proposal this year with additional data stating that there was little of risk of tumors developing.
Studies conducted by Arena revealed that overweight or obese patients who took Belviq had an average weight loss of 3 to 3.7 percent of their original body weight over the course of a year. Of the patients without diabetes, 47 percent lost at least five percent or more of their weight enough to meet the FDAs effectiveness standards.
I know were in the middle of an obesity epidemic and every effort has to be made to correct this serious medical situation. But while this drug seemed to help in certain patients with the struggle for long-term weight loss, I am still very skeptical that medications are the answer.
I am sure that the FDA has carefully looked at the safety concerns for this pill. However, what worries me is the modest weight loss obtained with the pill.
The FDA has standards for effectiveness, which are usually targets of about 5 percent weight loss or more, but as I mentioned earlier, the data showed that some patients only lost three percent of their body weight. This is a very small amount for a years length of time.
While the pill is going in the right direction, the results of these studies tell me that people should not rely on a pill to lose weight, but instead look at their overall health and lifestyle choices in order to achieve better weight loss numbers.
Remember, theres never a silver bullet for anything in health care.
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Dr. Manny: New FDA approved anti-obesity pill no 'silver bullet'
FDA approves 1st new weight loss drug in 10 years
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(CBS News) The obesity pill Belviq (lorcaserin) has been approved by the U.S. Food and Drug Administration to be used in conjunction with diet and exercise as a weight management treatment option. It's the first new long-term weight loss drug to hit the U.S. market in over a decade.
The FDA announced Wednesday that the drug is approved for adults with a body mass index (BMI) of 30 or over - which indicates obesity - or with a BMI of 27 or greater (overweight) who have at least one weight-related health problem such as high blood pressure, Type 2 diabetes or high cholesterol. It is manufactured by Switzerland-based Arena Pharmaceuticals.
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"Obesity threatens the overall well being of patients and is a major public health concern," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in a written statement. "The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition."
There are currently two prescription drugs used to treat obesity including the appetite-suppressant phentermine, and orlistat (Xenical), which prevents dietary fat from being absorbed by the intestine. Orlistat is sold over-the-counter as Alli in a lower dose.
The FDA cited three studies of nearly 8,000 overweight and obese patients - with or without Type 2 diabetes - who were treated from 52 weeks to 104 weeks with the drug or a placebo, along with exercise and diet counseling. The studies found about 47 percent of patients without Type 2 diabetes lost at least 5 percent of their body weight compared with about 23 percent of patients treated with placebo. In people with Type 2 diabetes, about 38 percent of patients treated with Belviq lost at least 5 percent of their body weight, compared to 16 percent in patients treated with placebo.
The drug's label will recommend that people stop taking the pill if they don't lose 5 percent of their body weight after 12 weeks of treatment, as those patients are unlikely to achieve meaningful weight loss even with continuing treatment. The drug should also not be taken by pregnant women.
Side effects from Belviq include serotonin syndrome - a potentially life-threatening drug reaction that causes the body to produce too much serotonin and causes symptoms of agitation, diarrhea, heavy sweating, fever, muscle spasms, tremors or mental health changes. People taking antidepressants or migraine drugs that increase serotonin levels may be at an increased risk for this side effect. The drug may also cause "disturbances in attention or memory," the FDA said.
Belviq should be used with caution in people who have congestive heart failure, according to the FDA, but studies found no significant difference in heart valve problems between people taking Belviq and those taking a placebo. Studies of some earlier weight loss pills reported heart valve damage as a potential side effect.
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FDA approves 1st new weight loss drug in 10 years
FDA OKs drug for long-term weight loss
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The Food and Drug Administration has approved Arena Pharmaceuticals anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in more than a decade.
Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDAs endorsement, amid calls from doctors for new weight-loss treatments.
The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol. The drug should be used in combination with a healthy diet and exercise.
Obesity Society President Patrick O'Neil said hes encouraged by the drugs approval because it underscores the notion that lifestyle changes alone are not enough to treat obesity.
This is good news because it tells us that the FDA is indeed treating obesity seriously, said Mr. ONeil, who teaches at Medical University of South Carolina and was the lead researcher on several studies of Belviq. On the other hand, its not the answer to the problem or even a big part of the answer.
Even if the effects of Belviq are subtle, experts say it could be an important first step in developing new treatments that attack the underlying causes of obesity.
The way these things tend to work is you have some people who do extremely well and other people dont lose any weight at all. But if we had 10 medicines that were all different and worked like this, we would have a real field, said Dr. Louis Aronne, director of the weight-loss program at Weill-Cornell Medical College.
The FDA denied approval for Arenas drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.
Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.
With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight-loss treatments.
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FDA OKs drug for long-term weight loss
FDA approves first diet prescription pill in 13 years
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by Associated Press
KING5.com
Posted on June 27, 2012 at 12:16 PM
Updated today at 4:59 PM
WASHINGTON -- The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.
Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.
The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol.
The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.
With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments.
But a long line of prescription weight loss offerings have been associated with safety problems, most notably the fen-phen combination, which was linked to heart valve damage in 1997. The cocktail of phentermine and fenfluramine was a popular weight loss combination prescribed by doctors, though it was never approved by FDA.
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FDA approves first diet prescription pill in 13 years
Belviq: First New Weight-Loss Pill Approved By FDA In Decade
Long Term Weight Loss Comments Off on Belviq: First New Weight-Loss Pill Approved By FDA In Decade
WASHINGTON The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.
Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.
The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol. The drug should be used in combination with a healthy diet and exercise.
Obesity Society President Patrick O'Neil said he's encouraged by the drug's approval because it underscores the notion that lifestyle changes alone are not enough to treat obesity.
"This is good news because it tells us that the FDA is indeed treating obesity seriously," said O'Neil, who teaches at Medical University of South Carolina and was the lead researcher on several studies of Belviq. "On the other hand, it's not the answer to the problem or even a big part of the answer."
Even if the effects of Belviq are subtle, experts say it could be an important first step in developing new treatments that attack the underlying causes of obesity.
"The way these things tend to work is you have some people who do extremely well and other people don't lose any weight at all. But if we had 10 medicines that were all different and worked like this, we would have a real field," said Dr. Louis Aronne, director of the weight loss program at Weill-Cornell Medical College.
The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.
Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.
With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments.
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Belviq: First New Weight-Loss Pill Approved By FDA In Decade
FDA clears first new prescription weight-loss pill in 13 years
Long Term Weight Loss Comments Off on FDA clears first new prescription weight-loss pill in 13 years
by Associated Press
KING5.com
Posted on June 27, 2012 at 2:33 PM
Updated today at 2:33 PM
WASHINGTON -- The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.
Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.
The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol.
The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.
"The approval of this drug, used responsibly in combination with a healthy diet and lifestyle, provides a treatment option for Americans who are obese or are overweight and have at least one weight-related comorbid condition," said FDA's drug center director, Dr. Janet Woodcock, in a statement.
Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.
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FDA clears first new prescription weight-loss pill in 13 years
FDA Approves First Weight-Loss Drug In 13 Yrs.
Long Term Weight Loss Comments Off on FDA Approves First Weight-Loss Drug In 13 Yrs.
WASHINGTON (AP) -- The Food and Drug Administration has approved Arena Pharmaceutical's anti-obesity pill Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade.
Despite only achieving modest weight loss in clinical studies, the drug appeared safe enough to win the FDA's endorsement, amid calls from doctors for new weight-loss treatments.
The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or high cholesterol. The drug should be used in combination with a healthy diet and exercise.
Obesity Society President Patrick O'Neil said he's encouraged by the drug's approval because it underscores the notion that lifestyle changes alone are not enough to treat obesity.
"This is good news because it tells us that the FDA is indeed treating obesity seriously," said O'Neil, who teaches at Medical University of South Carolina and was the lead researcher on several studies of Belviq. "On the other hand, it's not the answer to the problem - or even a big part of the answer."
Even if the effects of Belviq are subtle, experts say it could be an important first step in developing new treatments that attack the underlying causes of obesity.
"The way these things tend to work is you have some people who do extremely well and other people don't lose any weight at all. But if we had 10 medicines that were all different and worked like this, we would have a real field," said Dr. Louis Aronne, director of the weight loss program at Weill-Cornell Medical College.
The FDA denied approval for Arena's drug in 2010 after scientists raised concerns about tumors that developed in animals studied with the drug. The company resubmitted the drug with additional data earlier this year, and the FDA said there was little risk of tumors in humans.
Arena and its partner Eisai Inc. of Woodcliff Lake, N.J., expect to launch the drug in early 2013.
With U.S. obesity rates nearing 35 percent of the adult population, many doctors have called on the FDA to approve new weight loss treatments.
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FDA Approves First Weight-Loss Drug In 13 Yrs.
Stepped-care intervention results in weight loss, at lower cost
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Public release date: 26-Jun-2012 [ | E-mail | Share ]
Contact: Patricia Lomando White laer@pitt.edu 412-624-9101 JAMA and Archives Journals
CHICAGO Although a standard behavioral weight loss intervention among overweight and obese adults resulted in greater average weight loss over 18 months, a stepped care intervention resulted in clinically meaningful weight loss that cost less to implement, according to a study in the June 27 issue of JAMA.
"Most weight loss programs are intensive during the initial weeks of treatment, become less intensive over time, and maintain a fixed contact schedule for participants irrespective of treatment success or failure. Intensive weight loss programs are costly and require substantial time commitments from the participants, making them impractical in many circumstances. An alternative is a stepped-care approach. It involves an initially low-intensity intervention that is increased if weight loss milestones are not achieved at fixed time points. Stepped care has been effective for treatment of other health conditions. In theory, stepped care could result in better weight loss than conventional therapy because treatment intensity is escalated if weight loss goals are not met during the treatment period," according to background information in the article. "If shown to be an effective and a lower cost alternative to traditional in-person programs, a stepped-care approach could prove to be a cost-effective means for obesity treatment."
John M. Jakicic, Ph.D., of the University of Pittsburgh, and colleagues examined whether a stepped-care weight loss intervention (STEP) would result in greater weight loss compared with a standard behavioral weight loss intervention (SBWI). The clinical trial included 363 overweight and obese adults (body mass index: 25-<40; age: 18-55 years, 33 percent nonwhite, and 83 percent female) who were randomized to SBWI (n = 165) or STEP (n=198). Participants were enrolled between May 2008 and February 2010 and data collection was completed by September 2011. All participants were placed on a low-calorie diet, prescribed increases in physical activity, and attended group counseling sessions ranging from weekly to monthly during an 18-month period. The SBWI group was assigned to a fixed program. Counseling frequency, type, and weight loss strategies could be modified every 3 months for the STEP group in response to observed weight loss as it related to weight loss goals.
Of the 363 study participants, 260 (71.6 percent) provided a measure of weight at the 18-month assessment. The researchers found that weight loss at 18 months was -7.6 kg (16.8 lbs.) in the SBWI group compared with -6.2 kg (13.7 lbs.) in the STEP group. The percentage change in weight from baseline to 18 months was -8.1 percent in the SBWI group compared with -6.9 percent in the STEP group.
Both groups had significant and comparable improvements in resting heart rate, blood pressure level, and fitness.
"From the payer perspective, the mean cost per participant was $358 for the STEP group and $494 for the SBWI group. Costs from the participant perspective also were lower in the STEP group ($427) per participant compared with the SBWI group ($863). From the societal perspective (i.e., the sum of payer and participant), the average cost for STEP was $785. This was significantly less expensive than the average cost for SBWI, which was estimated to be $1,357," the authors write.
The researchers add that using the base-case cost estimates, they found that from the societal perspective, relative to status quo, the incremental cost-effectiveness ratio for STEP was $127 per 1 kg (2.2 lbs.) of weight lost. "The incremental cost-effectiveness ratio for SBWI, relative to the less expensive STEP, was $409 per 1 kg of weight lost. From the payer perspective, the incremental cost-effectiveness ratios were reduced to $58 per 1 kg of weight lost for STEP and $97 per 1 kg of weight lost for SBWI."
"Among overweight and obese adults, the use of SBWI resulted in a greater mean weight loss than STEP over 18 months. STEP resulted in clinically meaningful weight loss that cost less to implement than SBWI. Whether this weight loss results in improved health-related outcomes warrants further investigation," the authors conclude.
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Stepped-care intervention results in weight loss, at lower cost
Study compares effect of 3 common diets on energy expenditure following weight loss
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Public release date: 26-Jun-2012 [ | E-mail | Share ]
Contact: Keri Stedman keri.stedman@childrens.harvard.edu 617-919-3114 JAMA and Archives Journals
CHICAGO In an examination of the effect on energy expenditure and components of the metabolic syndrome of 3 types of commonly consumed diets following weight loss, decreases in resting energy expenditure and total energy expenditure were greatest with a low-fat diet, intermediate with a low-glycemic index diet, and least with a very low-carbohydrate diet, suggesting that a low-fat diet may increase the risk for weight regain compared to the other diets, according to preliminary research published in the June 27 issue of JAMA.
"Many people can lose weight for a few months, but most have difficulty maintaining clinically significant weight loss over the long term. According to data from the National Health and Nutrition Examination Survey (1999-2006), only 1 in 6 overweight and obese adults report ever having maintained weight loss of at least 10 percent for 1 year," according to background information in the article. One explanation for the poor long-term outcome is that weight loss elicits biological adaptationsspecifically a decline in energy expenditure and an increase in hungerthat promote weight. According to the authors, the effect of dietary composition on energy expenditure during weight-loss maintenance has not been studied.
Cara B. Ebbeling, Ph.D., of Children's Hospital Boston, and colleagues conducted a study to evaluate the effects of 3 weight-loss maintenance diets on energy expenditure, hormones, and components of the metabolic syndrome. The study, conducted between June 2006 and June 2010, included 21 overweight and obese young adults. After achieving 10 percent to 15 percent weight loss while consuming a run-in diet, participants consumed an isocaloric low-fat diet (60 percent of energy from carbohydrate, 20 percent from fat, 20 percent from protein; high glycemic load), low-glycemic index diet (40 percent from carbohydrate, 40 percent from fat, and 20 percent from protein; moderate glycemic load), and very low-carbohydrate diet (10 percent from carbohydrate, 60 percent from fat, and 30 percent from protein; low glycemic load) in random order, each for 4 weeks. The primary outcome measured was resting energy expenditure (REE), with secondary outcomes of total energy expenditure (TEE), hormone levels, and metabolic syndrome components.
The researchers found that energy expenditure during weight-loss maintenance differed significantly among the 3 diets. The decrease in REE from pre-weight-loss levels, measured by indirect calorimetry in the fasting state, was greatest for the low-fat diet (average relative to baseline, -205 kcal/d), intermediate with the low-glycemic index diet (-166 kcal/d), and least for the very low-carbohydrate diet (-138 kcal/d). The decrease in TEE also differed significantly by diet (average -423 kcal/d for low fat; -297 kcal/d for low glycemic index; and -97 kcal/d for very low carbohydrate).
"Hormone levels and metabolic syndrome components also varied during weight maintenance by diet (leptin; 24-hour urinary cortisol; indexes of peripheral and hepatic insulin sensitivity; high-density lipoprotein [HDL] cholesterol; non-HDL cholesterol; triglycerides; plasminogen activator inhibitor 1; and C-reactive protein), but no consistent favorable pattern emerged," the authors write.
"The results of our study challenge the notion that a calorie is a calorie from a metabolic perspective," the researchers write. "TEE differed by approximately 300 kcal/d between these 2 diets [very low-carbohydrate vs. low-fat], an effect corresponding with the amount of energy typically expended in 1 hour of moderate-intensity physical activity."
"These findings suggest that a strategy to reduce glycemic load rather than dietary fat may be advantageous for weight-loss maintenance and cardiovascular disease prevention. Ultimately, successful weight-loss maintenance will require behavioral and environmental interventions to facilitate long-term dietary adherence. But such interventions will be most effective if they promote a dietary pattern that ameliorates the adverse biological changes accompanying weight loss," the researchers conclude.
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Study compares effect of 3 common diets on energy expenditure following weight loss