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Apr 25, 2007

FDA Advisory Committee Vouched Unanimously for Sanction of Pfizer’s HIV Medication

  • Pfizer reports that FDA’s Antiviral Drugs Advisory Committee voted unanimously (12-0) to recommend the approval of its HIV drug. If given the go ahead, maraviroc would be the first member of a new class of oral HIV medicines in more than a decade, according to the company.

    Maraviroc is a CCR5 antagonist and blocks the virus’ predominant entry route, the CCR5 co-receptor, thus preventing its entry into uninfected cells.

    Pfizer has filed for approval of the drug to be used along with other antiretroviral agents for treatment-experienced patients infected with CCR5-tropic HIV-1. The company still awaits final approval from FDA through an expedited regulatory review.

    Pfizer says that it has a robust risk management plan for maraviroc through long-term follow up of ongoing clinical trials, pediatric studies, and pharmacovigilance, including a database study and a patient registry.

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Scientifically Studying Ecstasy

MDMA (commonly known as the empathogen “ecstasy”) is classified as a Schedule 1 drug, which is reserved for compounds with no accepted medical use and a high abuse potential. Two researchers from Stanford, however, call for a rigorous scientific exploration of MDMA's effects to identify precisely how the drug works, the data from which could be used to develop therapeutic compounds.

Do you agree that ecstasy should be studied for its potential therapeutic benefits?

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