Abbott Takes Diet Drug Meridia (Sibutramine) Off The Market
Oct08

Abbott Takes Diet Drug Meridia (Sibutramine) Off The Market

A diet pill bit the dust today- the Food and Drug Administration has asked Abbott Laboratories to take its drug Meridia off the market in the U.S. Meridia, or sibutramine, was approved by FDA in 1997, but the company voluntarily pulled Meridia after FDA's request, and is also halting sales of the drug in Canada and Australia. FDA's request was based mostly on a large study from last fall called the SCOUT trial. The trial suggested that patients on Meridia had more cardiovascular events, such as heart attacks and strokes, compared to patients taking a placebo. “Meridia’s continued availability is not justified when you compare the very modest weight loss that people achieve on this drug to their risk of heart attack or stroke,” said John Jenkins, M.D., director of the Office of New Drugs in the FDA’s Center for Drug Evaluation and Research (CDER), in an FDA press release. “Physicians are advised to stop prescribing Meridia to their patients and patients should stop taking this medication. Patients should talk to their health care provider about alternative weight loss and weight loss maintenance programs,” Jenkins said. Meridia was already pulled from the market in the UK and other European nations earlier this year. You can click here to read more about how the drug works. And last month an FDA advisory panel was split as to whether to keep Meridia on the market here in the U.S. Of 16 panelists, 8 voted to withdraw the drug, 2 voted to keep it on the market with more strict warning label language, and 6 voted to keep it on the market with label revisions and restrictions on which doctors can prescribe the drug. The loss of Meridia isn't a big blow to Abbott's stock. Prescriptions for Meridia have already dropped over the years because of safety concerns, from a high of 1.3 million prescriptions in 1998 to 250,000 in 2009, according to FDA. But the next wave of obesity drug news, should it be similarly negative, could take a bigger toll on the companies involved, which are both smaller than Abbott. Mark your calendars for October 22 and October 28- these are the goal dates for FDA to finish reviewing applications for Arena Pharmaceuticals' drug candidate Lorqess and Vivus' Qnexa. FDA panels have recommended against approving both drugs. UPDATED 3:59 PM- to reflect withdrawal of Meridia from Canada and Australia as well as...

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FDA Panel Thumbs-Down For Arena and Eisai’s Diet Pill Lorcaserin (Lorqess)
Sep17

FDA Panel Thumbs-Down For Arena and Eisai’s Diet Pill Lorcaserin (Lorqess)

Yesterday brought yet another disappointment to the obesity drug development field- an FDA panel recommended rejecting Arena and Eisai's potential diet pill lorcaserin (Lorqess) by a vote of 9 to 5. The message from the panelists was that not enough data was available to assuage concerns about safety, as well as concerns about how the drug would work in a wider population. This marks the second thumbs-down for a prospective obesity drug this year. Vivus's drug candidate Qnexa received a 'no' vote from the panel in July. Going into the yesterday's panel, the mood wasn't exactly sunny. As I wrote yesterday, the FDA briefing documents for lorcaserin contained an unexpected safety surprise. The agency was concerned about malignancies that cropped up in rats taking high doses of lorcaserin. And Arena's stock had tanked on the news. At the panel, Arena tried to allay FDA's concerns right off the bat- in its presentation to the panel, the company said that the tumors were attributable to rat-specific mechanisms, so they wouldn't apply to people. The company even presented a slide listing FDA approved drugs that showed higher rates of rat cancers than lorcaserin (I do not have this information but will update if I get it). The company reiterated that in clinical trials, patients taking lorcaserin did not have an increased risk of cancer. FDA's briefing documents also contained a safety note about heart valve problems. As I've written before, lorcaserin had a lot to prove in this department. It targets the same serotonin receptor as fenfluramine, an ingredient in the infamous Fen-Phen obesity drug combo. Fenfluramine was associated with heart valve damage and a fatal lung disorder- it was pulled from the market in 1997. But lorcaserin is different from fenfluramine- it is more selective for one specific subtype of serotonin receptor and avoids the one that’s found in the heart. Arena had surmised that this would help avoid the valve problems that plagued fenfluramine, and the company has had to pay special attention to heart valve safety throughout lorcaserin’s development. The reason FDA is concerned is that their statistical analysis of Arena's heart valve data (using a different method from Arena) suggests a risk for heart valve damage for patients on lorcaserin. FDA said the company could not statistically rule out a 50% increase in the risk of heart valve problems. At the panel, Arena defended its own data and statistics and said it was committed to continued safety monitoring in a post-approval period. But at the end of the day, it was the safety-efficacy balance that led to the thumbs-down vote from FDA's panel. As I wrote back...

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