Pfizer won accelerated approval from the FDA for Selzentry, the first HIV therapy in a new class of drugs in a decade. The drug (maraviroc) is a CCR5 antagonist, which prevents the virus from entering white blood cells. The process reduces viral load and boosts T-cell count. In the next step of regulatory review, Pfizer will provide additional data to gain a traditional approval of the drug. The approval is notable for a variety of reasons. For Pfizer, it's a much-needed win on the regulatory side after a series of disappointing setbacks in its pipeline development program. For the FDA, the accelerated approval may help tone down some growing complaints that the agency has grown shy about swift approvals in light of a number of safety problems with therapeutics.
- see the release on the approval
- here's the Forbes report
ALSO: Pfizer has updated its public R&D pipeline site for the first time since it went online in December. FiercePharma
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