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Weight Loss Pill Belviq Gets FDA Approval

Posted: June 28, 2012 at 11:23 am

Featured Article Main Category: Obesity / Weight Loss / Fitness Also Included In: Regulatory Affairs / Drug Approvals Article Date: 28 Jun 2012 - 3:00 PDT

Current ratings for: Weight Loss Pill Belviq Gets FDA Approval

Belviq (lorcaserin hydrochloride), made by the Swiss pharma company Arena, is the first prescription diet drug to receive US federal approval in over a decade. It works by activating the serotonin 2C receptor in the brain, an effect that may help the patient feel full after eating smaller amounts of food and thereby eat less.

Dr Janet Woodcock, director of the Center for Drug Evaluation and Research at the FDA, told the press:

"Obesity threatens the overall well being of patients and is a major public health concern."

FDA says the drug is approved for use in adults who are obese, or adults who are overweight and have at least one weight-related condition, such as type 2 diabetes, high blood pressure, or high cholesterol.

"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 Woodcock.

The agency defines obesity as having a BMI of 30 or over, and overweight as having a BMI under this but no less than 27. BMI stands for Body Mass Index, and equals weight in kilos divided by the square of height in metres.

BMI is used by health authorities and policymakers as a measure of body fat. According to the US Centers for Disease Control and Prevention (CDC), more than one in three of adult Americans is obese.

The approved label for Belviq recommends that patients stop using it if they fail to lose 5% of their body weight after 12 weeks of treatment, as "these patients are unlikely to achieve clinically meaningful weight loss with continued treatment," says the FDA in their announcement.

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Weight Loss Pill Belviq Gets FDA Approval

FDA approves first new weight-loss pill in 13 years

Posted: June 28, 2012 at 11:23 am

Posted: 2:36 pm Wed, June 27, 2012 By Associated Press

WASHINGTON 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 over 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 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.

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 FDAs drug center director, Dr. Janet Woodcock, in a statement.

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.

In a rare move, the FDA explicitly stated in a press release that Belviq does not appear to activate a chemical pathway that was linked to the heart problems seen with fen-phen.

The FDA said the drug acts on a different chemical pathway in the brain, which is believed to reduce appetite by boosting feelings of satiety and fullness.

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FDA approves first new weight-loss pill in 13 years

FDA clears first new prescription weight-loss pill in 13 years

Posted: June 28, 2012 at 11:23 am

by Associated Press

KING5.com

Posted on June 27, 2012 at 2:33 PM

Updated yesterday 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 clears first new weight-loss pill in 13 years – Wed, 27 Jun 2012 PST

Posted: June 28, 2012 at 11:23 am

June 27, 2012 in Health

MATTHEW PERRONE AP Health Writer

(AP Photo/Food and Drug Administration) photo

This photo provided by Food and Drug Administration shows Arena Pharmaceuticals anti-obesity pill Belviq. The Food and Drug Administration has approved Belviq, the first new prescription drug for long-term weight loss to enter the U.S. market in over a decade. The agency cleared the pill Wednesday for adults who are obese or are overweight with at least one medical complication, such as diabetes or highcholesterol. (Full-size photo)

WASHINGTON (AP) 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 over 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 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.

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 FDAs drug center director, Dr. Janet Woodcock, in a statement.

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FDA clears first new weight-loss pill in 13 years - Wed, 27 Jun 2012 PST

FDA Approves First Weight-Loss Drug In 13 Yrs.

Posted: June 28, 2012 at 11:23 am

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.

Extreme diet helps fuel major weight loss

Posted: June 28, 2012 at 11:23 am

When Mark Reichenbach's mother died in 2008, the grieving son had to rent a suit for the funeral. He didn't own one because for someone 5 feet 5 inches with a 64-inch waist, clothes were hard to find and higher priced than normal.

The rented jacket fit so poorly, he didn't wear it. "I was so embarrassed. It had big brass buttons on it; I looked like a greeter at a casino. There I was at my mother's funeral dressed like that."

That same day he vowed that nothing like that would happen to him again.

He's not sure of his exact weight at the time, but it was the largest he'd ever been. He found an adequate scale some time later: 440 pounds.

Today, Reichenbach, 43, is between 190 and 200 pounds. He lifts weights and walks for regular exercise. "I want more aerobics," he said. "I'm working not to be big, not get bigger."

At work in his job as a security officer, he walks up and down six flights of steps nine times a day.

He has incorporated more walking into his life. For example, he shops at farmers markets, which require a lot of walking.

"I used to just work and sleep," he said. "Now, I have so much energy."

He has taught himself yoga from a textbook. He jumps rope.

"I cook 90 percent of my own meals," he said. He eats mostly vegetables and fruits.

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Extreme diet helps fuel major weight loss

Eating Dessert With Breakfast Helps Dieters

Posted: June 27, 2012 at 9:20 pm

June 26, 2012

Connie K. Ho for redOrbit.com

Chocolate cake. Crme filled donuts. These are some of the options people can look forward to having for breakfast after a new study highlighted the role dessert has in breakfast for dieters. Researchers at Tel Aviv University recently found that a diet focused on dessert with breakfast can actually help people avoid weight gain by decreasing the cravings they have.

The findings were presented at the Endocrine Societys 94 Annual Meeting recently in Houston and published in the March issue of the journal Steroids. The researchers believe that a carbohydrate-rich, protein-packed breakfast with dessert will help dieters be less hungry and not have as many cravings throughout the day. This, in turn, will help dieters keep off lost weight.

The goal of a weight loss diet should be not only weight reduction but also reduction of hunger and cravings, thus helping prevent weight regain, remarked Dr. Daniela Jakubowicz, the studys principal investigator, in a prepared statement.

Jakubowicz, a senior physician at the Wolfson Medical Center of Tel Aviv University, and co-authors looked at 200 nondiabetic obese adults. These individuals participated in one of two low-calories diets. Both diets had the same number of daily calories, around 1,600 calories for men and 1,400 for women. However, the diets were composed of different items. While one group had a low-carbohydrate diet that had a 304-calorie breakfast with only 10 grams of carbohydrates, the other group had a 600-calorie breakfast with 60 grams of carbs of a small sweet like chocolate, cake, cookie or doughnut. Both diets had protein options like egg whites, cheese, low-fat milk, and tuna at breakfast. However, the dessert with breakfast diet featured 45 grams of protein, 15 more grams than the low-crab diet.

The study was done over an eight-month period and, midway through the experiment, participants reported an average of 33 pounds lost per person. Jakubowicz believes that these results show that both diets work the same. In the last months of the study though, the low-carbohydrate group regained around 22 pounds per person. On the other hand, study subjects of the dessert with breakfast diet group lost another 15 pounds each.

Furthermore, those participants who ate dessert with breakfast stated that they felt less hungry and had fewer cravings when compared to the other group. The food diaries from these subjects showed that they had less difficulty in sticking with their calorie requirements. Women who were part of the dessert with breakfast diet group were able to have 500 calories for lunch and 300 calories for dinner. Men in the same group could consume a 600-calorie lunch and as much as 464 calories for dinner. Further evidence shows that a hunger hormone called ghrelin had lower levels after breakfast in the dessert with breakfast diet group than the low-carbohydrate diet group (45.2 percent versus 29.5 percent).

Researchers propose that the better results from the dessert with breakfast diet group were based on meal timing and composition. In particular, Jakubowic credits the diets high protein content to reducing hunger. She also believes that the mix of protein and carbohydrates made people feel fuller and decreased their wants for sweet, starchy, and fatty foods. These cravings normally arise or come about when a diet limits the amount of sweets a person can have, which can cause people to eat more fattening foods.

Source: Connie K. Ho for redOrbit.com

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Eating Dessert With Breakfast Helps Dieters

Life partner: Microbes, at work inside of us, are of rising interest to researchers for role in health, diet

Posted: June 27, 2012 at 9:20 pm

The Harvard lab of Bauer Fellow Peter Turnbaugh (above) is working to identify the mysterious microbes living in our intestines, and to better understand how the bacteria that live within us affect the drugs we take and the exotic foods we eat, collectively called xenobiotics. There are very few examples where we know the link between gut microbes and xenobiotics thats one thing Id like to change, Turnbaugh said. Credit: Kris Snibbe/Harvard Staff Photographer

Without the bacteria that live in our intestines, a drug used against rheumatoid arthritis and inflammatory bowel disease wouldnt work.

The microbes produce an enzyme that cleaves and activates a key molecule in the drug. Scientists know the microbes responsible are there and that this activity is important, but they dont know which microbes are responsible, or even how many kinds provide this service.

Another type of intestinal bacteria can keep drugs from reaching target tissue, altering a Parkinsons disease treatment in the same way the brain would, preventing absorption. Researchers believe that differences in patients microbial communities could account for the drugs variable effectiveness. The culprit microbe, again, is unknown.

The Harvard lab of Bauer Fellow Peter Turnbaugh is working to identify these mysterious microbes, and to better understand how the bacteria that live within us affect the drugs we take and the exotic foods we eat, collectively called xenobiotics.

There are very few examples where we know the link between gut microbes and xenobiotics thats one thing Id like to change, Turnbaugh said. I think were really at the very beginning.

This month, some 200 scientists from 80 institutions, including Harvard and the Broad Institute of Harvard and MIT, filled in some of the blanks. They announced results from the massive Human Microbiome Project, a government-funded effort to uncover the scale and diversity of the microbes we carry and to analyze their genomes to provide tools for future researchers.

The scientists found that we carry some 100 trillion bacteria from some 1,000 different strains, many of which are new to science and some of which, though known to cause disease, were found living peaceably among 250 healthy volunteers.

Though there was understanding in the past that the microbes we carry affect our health, the advanced tools of genomics have fostered recent progress, Turnbaugh said. In a recent article in the journal Science, Turnbaugh and postdoctoral fellow Henry Haiser argued that a better understanding of our microbes metabolic activity and how they interact with our bodies in ways that both promote health and cause illness could revolutionize how we understand and treat disease.

Postdoctoral fellows, interns, and other researchers in Turnbaughs lab, which is not part of the Human Microbiome Project, are at work on 10 to 15 projects. Though the human body has microbes in many places including the mouth, intestines, and skin Turnbaugh has been focusing on those in the intestines. He collects samples from the feces of volunteers and from gnotobiotic laboratory mice, born and maintained in a microbe-free environment before they are colonized experimentally. Using an oxygen-free incubation chamber to grow microbe colonies that favor the anaerobic intestinal conditions, as well as cell-sorters and gear that aids advanced genomic analysis, researchers are investigating a variety of questions.

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Life partner: Microbes, at work inside of us, are of rising interest to researchers for role in health, diet

FDA approves first diet prescription pill in 13 years

Posted: June 27, 2012 at 9:20 pm

by Associated Press

KING5.com

Posted on June 27, 2012 at 12:16 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.

In a rare move, the FDA explicitly stated in a press release that Belviq "does not appear to activate" a chemical pathway that was linked to the heart problems seen with fen-phen.

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FDA approves first diet prescription pill in 13 years

Low-Glycemic Diet Best For Maintaining Weight Loss

Posted: June 27, 2012 at 9:20 pm

Lawrence LeBlond for redOrbit.com

Diets based on healthy carbohydrates and not on low-fat may offer dieters a better chance of burning calories and keeping weight off and without unwanted side effects, according to a new study published Tuesday in the Journal of the American Medical Association.

The research suggests that dieters trying to maintain weight loss burned significantly more calories eating a carb-healthy diet rather than a low-fat diet, but some experts say the results are still preliminary.

The National Institutes of Health-funded study, led by Cara Ebbeling, PhD, associate director and David Ludwig, MD, director of the New Balance Foundation Obesity Prevention Center Boston Childrens Hospital, found that diets that reduce the surge in blood sugar after a meal (low-glycemic index or very-low carb) may be more beneficial to those trying to achieve lasting weight loss.

Participants in the study who followed a low-glycemic-index diet, which includes fish, fruit, vegetables, nuts and whole grains, also saw improved cholesterol levels and other important markers that lower the risks of developing heart disease and diabetes. The researchers said that foods such as minimally processed oatmeal, almonds, brown rice, beans and healthy fats like olive oil, and other similar foods also offer beneficial results.

Furthermore, the study found that the low-glycemic diet had similar metabolic benefits to the very-low-carb diet without negative effects of stress and inflammation as seen by participants consuming the foods in the very-low-carb diet.

Ludwig explained that most people struggle to keep weight off. Previous studies have shown that weight loss reduces the bodys daily energy expenditure (how many calories the body burns through activity and just by resting) making it easy to regain weight.

The studys 21 participants, who ranged in age from 18 to 40 years old, lost 10 to 15 percent of their body weight during the three-month diet that contained about 45 percent of total calories from carbohydrates, 30 percent from fat, and 25 percent from protein.

One month after the weight-loss phase of the study, the participants were each placed on one of the three diets: low-fat, very-low-carb, and low-glycemic-index. The participants were then switched to the other two diets during two additional four-week periods.

The low-fat diet consisted of about 20 percent calories from fat, 60 percent from carbs, and 20 percent from protein; the low-carb diet consisted of 10 percent of calories from carbs, 30 percent from proteins, and 60 percent from fat; and the low-glycemic diet was made up of 40 percent calories from carbs, 40 percent from fat, and 20 percent from protein.

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Low-Glycemic Diet Best For Maintaining Weight Loss


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