FDA notes concerns about Vivus diet pill safety ahead of panel

Posted under Blog, Companies, Diagnostics, FDA expert panels, Funding, Medical Devices, Medical Supply, obesity, Pharmaceuticals, Qnexa, Startups, Universities, Videos, Vivus by Ryan McBride

U.S. regulators have cited concerns about the safety of Vivus’ ($VVUS) experimental diet pill Qnexa in review documents as the California drug developer pursues the first FDA approval of a weight-loss drug in more than a decade.

Vivus is taking a second shot at a market nod for the drug, which regulators rejected in 2010 because of the potential for heart problems and birth defects. The company now has come back to the table with data from a safety study and a plan to limit use of the drug in women who become pregnant. A panel of experts will weigh in Wednesday on the company’s application and vote on whether the FDA should give the developer its long-sought approval.

New obesity drugs have been a risky bet in the biopharma world because of the safety hurdles that companies must overcome. Industry watchers are keen to see how regulators treat Vivus’ latest bid for approval as a harbinger in the diet pill arena.

While there might not be burning red flags in the latest FDA review documents about new safety concerns, staffers noted: “For each weight change category, the PHEN/TPM-treated subjects had a higher increase in mean heart rate compared to placebo-treated subjects from baseline to Week 56,” according to the documents released this morning. Cardiovascular risks have plagued past obesity treatments, and the success of Qnexa could hinge on how regulators view the risks versus the benefits of the drug.

Vivus has been able to show in past studies that Qnexa can deliver weight-loss benefits for patients. In fact, as The New York Times reported this week, doctors are already prescribing the two drugs that are combined in Qnexa--phentermine and topiramate--to help patients lose weight.

About one in three Americans is considered obese, according to the Centers for Disease Control and Prevention, and the biopharma industry would love to seize this huge market opportunity by selling new weight-loss drugs. In addition to Vivus, Orexigen Therapeutics and Arena Pharmaceuticals are two notable developers in the hunt to advance new diet pills onto the U.S. market.

- here's the AP story
- see The New York Times article
- and an update from Reuters

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Eisai loses panel vote on new Dacogen use

Posted under Blog, Companies, Dacogen, Diagnostics, Eisai, FDA expert panels, Funding, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

A federal advisory panel voted down Eisai's attempt to gain an approval for Dacogen as a treatment for acute myeloid leukemia. The pharma company has been trying to gain an OK to use the drug for elderly patients for whom chemo has failed. The advisers voted 10 to 3 against, making any formal approval unlikely. Story

FDA commish counters industry critics on expert conflict rules

Posted under Blog, Companies, Diagnostics, FDA expert panels, Funding, Margaret Hamburg, Medical Devices, Medical Supply, Pharmaceuticals, Startups, Universities, Videos by John Carroll

There's been an ongoing debate in biopharma circles over the impact a shortage of drug experts is having on the FDA's panel review process. But anyone looking for the agency to welcome changes in the rules governing conflicts of interest--which have been keeping some of the experts at bay--can rule out any support from FDA Commissioner Margaret Hamburg.

In testimony to Congress this week, Hamburg made it crystal clear that the agency isn't supporting any new legislative initiatives to ease the 4-year-old set of rules, despite calls from supporters who say the changes would significantly reduce approval times and enhance innovation in the industry. The FDA has more than enough waivers to use if the agency believes that it needs to get more panelists, says the commissioner.

"At the present time, we are not bumping up against our cap in terms of waivers," Hamburg told a House committee, according to a report in Reuters. "We don't at the moment see major areas where a legislative fix is required."

Patient advocacy groups are likely to cheer that position. But it won't sit well with many on the drug development side of the fence, especially as critics constantly roast the agency over what they see as an unresponsive bureaucracy that moves far too slowly.

"Our view is there is a need to improve the process of the advisory committees, particularly in areas where there is a paucity of experts," noted Geno Germano, president of Pfizer's ($PFE) specialty care and oncology unit, according to Reuters.

Given the difference of opinion, this is one issue not likely to go away anytime soon.

- here's the story from Reuters

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