Make us your home page
Instagram

Today’s top headlines delivered to you daily.

(View our Privacy Policy)

FDA approves new weight-loss pill Belviq

Arena Pharmaceutical’s weight-loss pill Belviq is for adults who are obese with at least one medical complication, such as diabetes or high cholesterol.

Associated Press

Arena Pharmaceutical’s weight-loss pill Belviq is for adults who are obese with at least one medical complication, such as diabetes or high cholesterol.

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 more than 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.

Obesity Society president Patrick O'Neil said he's encouraged by the drug's approval because it underscores the idea 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. On the other hand, it's not the answer to the problem — or even a big part of the answer," said O'Neil, who teaches at Medical University of South Carolina and was the lead researcher on several studies of Belviq.

Even if the effects of Belviq are subtle, experts say it could be an important first step in a new line of 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," said Dr. Louis Aronne, director of the weight loss program at Weill-Cornell Medical College. "But if we had 10 medicines that were all different and worked like this, we would have a real field."

FDA approves new weight-loss pill Belviq 06/27/12 [Last modified: Wednesday, June 27, 2012 10:27pm]
Photo reprints | Article reprints

© 2017 Tampa Bay Times

    

Join the discussion: Click to view comments, add yours

Loading...
  1. Astros rout Yankees to force Game 7 of AL Championship Series

    Ml

    HOUSTON — Justin Verlander pitched seven shutout innings to outduel Luis Severino for the second time, and the Astros bats came alive in their return home as Houston routed the Yankees 7-1 Friday night and forced a decisive Game 7 in the American League Championship Series.

    The Astros’ Brian McCann, who has struggled during the ALCS, breaks a scoreless tie with an RBI double during the fifth inning off Yankees starter Luis Severino.
  2. Review: Faith Hill and Tim McGraw shower love, star power on Tampa's Amalie Arena

    Blogs

    Near the end of their potent new duet Break First, Tim McGraw stopped singing, and let Faith Hill's powerhouse voice take over.

    Faith Hill and Tim McGraw performed at Amalie Arena in Tampa on Oct. 20, 2017.
  3. Senate to take up AUMF debate as Trump defends reaction to Niger attack

    World

    WASHINGTON — The Senate Foreign Relations Committee is taking up a long-awaited debate about authorizing military force against the Islamic State as President Trump comes under unprecedented public scrutiny for his treatment of dead soldiers' families, following an ambush on troops helping to fight Islamic …

  4. In fear and vigilance, a Tampa neighborhood holds its breath

    K12

    TAMPA — There was a time, not long ago, when Wayne Capaz would go for a stroll at night and Christina Rodriguez would shop whenever she wanted. Michael Fuller would go to his night job as a line cook, not too worried about his wife at home.

    More than 50 people gathered and walked in the Southeast Seminole Heights community Friday to pay respects to the victims of three shootings. The crowd took a moment of silence at the corner of 11th Street and East New Orleans where Monica Hoffa was found dead. [JONATHAN CAPRIEL  |  Times]
  5. Fennelly: What's not to like about Lightning's start?

    Lightning Strikes

    BRANDON — No one is engraving the Stanley Cup. No one has begun stuffing the league MVP ballot box for Nikita Kucherov.

    The Lightning, with a win tonight, would match the best start in franchise history, 7-1-1 in the 2003-04 Cup season.