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 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.

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.

Read more here:
FDA OKs new weight-loss pill

By JoNel Aleccia

Federal Food and Drug Administration officials approved a new weight-loss pill Wednesday, giving the nod to Belviq used in combination with a reduced-calorie diet and exercise to combat obesity.

The Arena Pharmaceuticals drug, which also goes by the generic name lorcaserin, is one of three new potential weight-loss treatments the agency is considering and the first new weight-loss medication approved in 13 years. More than two-thirds of adult Americans are overweight or obese.

"Obesity threatens the overall well-being of patients and is a major public health concern," said Dr. Janet Woodcock, the director of the FDA's Center for Drug Evaluation and Research.

Lorcaserin was initially rejected because of concerns about safety issues, particularly concerns about heart valve problems, but a panel this spring agreed that the drug from Arena in conjunction with the Japanese firm Eisai Inc. was now suitable for use.

The drug works by activating a receptor in the brain that may help a person eat less and feel full after eating smaller amounts of food.

It is approved for use in obese adults with a body mass index or BMI of 30 or greater and in overweight adults with a BMI of 27 or greater if they have at least one weight-related condition such as high blood pressure, type 2 diabetes or high cholesterol. For example, a 5-foot-7 woman who weighed 192 pounds would have a BMI of 30.

The drug was tested in three randomized, placebo-controlled clinical trials involving nearly 8,000 obese and overweight patients, including those with and without type 2 diabetes. They were treated for 52 to 104 weeks. All participants agreed to diet and exercise regimens. Compared with use of a placebo, or sugar pill, patients treated with Belviq for up to one year lost an average of 3 percent to 3.7 percent of their body weight.

Nearly half of patients without diabetes lost at least 5 percent of their body weight, compared with about a quarter of those who took placebos. In people with diabetes, about 38 percent treated with lorcaserin lost 5 percent of their body weight, compared with about 16 percent treated with placebos.

The drug is recommended to be discontinued in patients who fail to lose 5 percent of body weight after 12 weeks of treatment because they appear to be unlikely to achieve "clinically meaningful" weight loss.

Link:
FDA OKs first new weight-loss pill in 13 years

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 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. 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.

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.

See the original post:
US clears first new weight-loss pill in 13 years

It's modestly effective and was initially denied in 2010, but Arena Pharmaceutical's diet drug, Belviq, won government approval on Wednesday, making it the first new weight-loss pill to enter the U.S. market in more than a decade.

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.

(MORE: A Brief History of Diet Drugs and the FDA)

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.

See the original post:
Belviq: FDA Approves the First New Weight-Loss Pill in 13 Years

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

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

Belviq is one of three experimental weight-loss drugs whose developers have been trying for a second time to win approval, after the FDA shot them all down in 2010 or early 2011 because of serious potential side effects.

Vivus Inc.'s Qnexa is thought to be the most promising of the drugs, achieving the most weight loss. But the FDA has delayed a decision on that pill until July.

See the original post here:
New weight-loss pill OK'd

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.

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.

Read the original here:
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 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.

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.

Go here to see the original:
FDA approves Belviq, the first new weight-loss pill in 13 years

COLUMBUS, Ohio (AP) As a political science major at Ohio State University, Ida Seitter says, she lit up many a cigarette to help her through the stress of exam season. Right or wrong, they were her security blanket as she toiled through college.

Seitter, now 26, was old enough by then to make her own decisions, she says. She opposes efforts by policymakers in Ohio, New York, California and other states to impose bans on tobacco use not just in buildings at public colleges, but also anywhere on the campus even in the open air.

Just back away from me a little bit. I wont blow it in your face and Ill try not to be rude, Seitter says. At the same time, I think its a little discriminatory for a practice that is considered legal.

Bans on tobacco in all its forms are being enacted or considered at perhaps half of campuses nationwide, sometimes over the objections of student smokers, staff and faculty. The movement is driven by mounting evidence of the health risks of secondhand smoke, the reduced costs of smoke-free dorms and a drive to minimize enticements to smoke at a critical age for forming lifelong habits.

Californias state system will bar tobacco use by August 2013. A ban on use and advertising at the City University of New York system goes into effect in September, and the University of Missouri at Columbia is going smoke-free in 2014.

Ohio higher education officials plan a vote next month urging all public campuses to ban tobacco use. That includes Ohio State, one of the nations largest universities, which currently bans only indoor smoking.

According to the surgeon generals report for 2012, tobacco use among people ages 18 to 25 remains at epidemic proportions nationwide. The review found 90 percent of smokers started by age 18, and 99 percent by age 26. About a quarter to a third of college students smoke, studies have found.

The study found the U.S. would have 3 million fewer young smokers if success in reducing youth smoking by state tobacco-cessation programs from 1997 to 2003 had been sustained. Many of the programs have been hit by budget cuts.

Health and education officials, anti-smoking groups and a generation of students who grew up smoke-free are increasingly united on the issue, says Bronson Frick, associate director of Americans for Nonsmokers Rights.

There are many reasons why a college or university may choose to pursue this type of policy, whether secondhand smoke, dorm fires, or other issues, he says. They are also questioning what the role of tobacco is in this academic setting, where were supposed to be standing for truth and training the next generation of leaders.

Follow this link:
FDA approves diet pill