FDA Panels Clear Arena Pharmaceuticals' Obesity Drug, Gilead Sciences' HIV PrEP
| Posted: 11 May 2012
By Alexander Gaffney
Advisory Committees for the US Food and Drug Administration (FDA) cleared two high-profile pharmaceutical products on 10 May that would, respectively, help patients to lose weight and prevent patients from contracting the Human Immunodeficiency Virus.
Arena Pharmaceuticals’ Lorcaserin:
The New York Times: “Government advisers recommended approval on Thursday of a weight-loss drug developed by Arena Pharmaceuticals, making it likely that a new obesity treatment will reach the market this year. An advisory committee to the Food and Drug Administrationvoted 18 to 4, with one abstention, that the benefits of the drug, lorcaserin, outweighed the risks. If the F.D.A. approves the drug by its scheduled deadline of June 27, lorcaserin would be the first new prescription diet pill to reach the market in 13 years. The agency does not have to follow committee recommendations, although it usually does.”
Pharmalot: “This marks the second time in three months that an FDA panel has decided the benefits of reducing the growing American waist line outweigh the various risks that have delayed this latest round of fat-fighting drugs from finding their way to medicine cabinets. Unlike the September 2010 advisory panel meeting, Arena was able to overcome concerns about a theoretical risk of an increase in cancer; valvulopathy, which is heart valve damage, and cardiovascular adverse events. Some committee members discussing the possbility of requiring echocardiograms before patients are prescribed Lorqess, given that an increased risk CV events could not be ruled out. Most likely, the FDA would require a post-approval outcomes study.”
Pharma Times: “Support for Lorqess comes a month after the FDA extended the PDUFA goal date from April 17 to July 17 for the New Drug Application on Vivus' rival obesity drug Qnexa (phentermine/topiramate), which was backed 20-2 by the agency's panel in February. Another weight loss drug, Orexigen Therapeutics/Takeda's Contrave (naltrexone/bupropion) is currently in a cardiovascular outcomes trial having also been turned down by the FDA earlier.”
Bloomberg Businessweek: “Some panel members suggested the FDA require lorcaserin to include a risk management plan that possibly screens patients for abnormalities before starting treatments and warns patients about the potential of developing a valve abnormality.
Gilead Sciences’ Truvada
CNN: “A U.S. Food and Drug Administration advisory committee recommended Thursday that the agency approve the drug, Truvada, for pre-exposure prophylaxis, or PrEP. The committee voted 19-3 in favor of approval for the prevention indication -- PrEP for HIV-uninfected men who have sex with men and 19-2 with one abstention for HIV-uninfected partners in couples where the other partner is infected. The committee recommended by 12-8 with two abstentions in favor of approving the drug for individuals who engage in risky sexual behavior that could result in their contracting the virus. Truvada, manufactured by Gilead Sciences, Inc., is a once-a-day pill used in combination with other HIV drugs. The nucleoside reverse transcriptase inhibitor does not rid the body of HIV. Instead, it prevents the virus from replicating in the body.”
Reuters: “But panel members expressed concern about prospective FDA guidelines that call for education and training for prescribing physicians but avoid basic restrictions on the availability of the treatment. Some said drug recipients should be required to undergo regular HIV screening to them from becoming HIV positive while taking the treatment and unknowingly passing drug-resistant HIV strains to their sexual partners.”
The New York Times: “Many panelists voiced concern on Thursday about the possibility that people who become infected while taking Truvada could develop dangerous drug-resistant strains of the virus, but the panel decided that the benefits of preventing new infections outweighed the risks.”
The Pink Sheet Daily: “The meeting bogged down late in the day, before the voting question, over the adequacy of Gilead’s proposed REMS. In accordance with FDA’s view, the plan did not link drug distribution to documented evidence of a negative HIV test. Individuals who test positive for HIV while taking Truvada for PrEP run the risk of developing viral resistance. Committee members said the proposed REMS, which focuses on voluntary prescriber training and education, needed to be more creative with more ‘teeth.’”