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Nelson Vergel
powerusa dot org

"I learned that...no one is perfect but most people are good; that people can't be judged only by the worst or weakest moments; that harsh judgements can make hypocrites of us all; that a lot of life is just showing up and hanging on; that laughter is often the best, and sometimes the only response to pain." My Life by Bill Clinton

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FDA ADVISORY COMMITTEE RECOMMENDS ACCELERATED APPROVAL OF PFIZER'S MARAVIROC FOR TREATMENT-EXPERIENCED PATIENTSINFECTED WITH CCR5-TROPIC HIV-1

Pfizer press release

NEW YORK, April 24 -- Pfizer Inc announced today that the U.S. Food and Drug Administration's (FDA) Antiviral Drugs Advisory Committee voted unanimously (12-0) to recommend the approval of maraviroc, a CCR5 antagonist, for use along with other antiretroviral agents for treatment-experienced patients infected with CCR5-tropic HIV-1.

If approved, maraviroc would be the first member of a new class of oral HIV medicines in more than a decade. Discovered by Pfizer scientists in 1997, maraviroc works by blocking viral entry to human cells. Rather than fighting HIV inside white blood cells, it prevents the virus from entering uninfected cells by blocking its predominant entry route, the CCR5 co-receptor.

In the pivotal MOTIVATE trials, nearly twice as many treatment-experienced CCR5-tropic HIV-1 infected patients treated with maraviroc plus optimized background therapy (OBT) achieved undetectable viral loads at 24 weeks compared to those receiving placebo plus OBT. (note from jules: the mean viral load reduction was about 1.9 log for maraviroc bid, 1.8 log for MVC qd, and 1 log for placebo after 24 weeks).

There were no significant increases in hepatotoxicity, malignancy or mortality in maraviroc's treatment arms, while there were slight increases in upper respiratory and herpes simplex virus infections as well as with ischemic events, consistent with the rate observed in treatment experienced HIV/AIDs patients.
Pfizer will carefully consider today's discussion and is committed to 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. Preliminary safety data beyond 24 weeks from the ongoing MOTIVATE trials were shared with the advisory panel today and the 48-week study outcomes will be submitted for presentation at a scientific forum later this year.

Maraviroc is currently undergoing expedited regulatory review. While the FDA is not bound by the Advisory Committee recommendations, in most cases, the FDA does follow the recommendations.





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