FierceBiotechFierceBioResearcherFierceVaccinesFiercePharma   FierceHealthcare

Free Newsletter

About | View Sample | Privacy
Related Topics >> Drug Safety | Pfizer | FDA approval | HIV/AIDS

Selzentry approval marks big win for Pfizer

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

Related Articles:
Investors yawn at Maraviroc endorsement. Report
New HIV drugs offer breakthrough therapies. Report

More stories about Drug Safety   Pfizer   FDA approval   HIV/AIDS  

Comments

Post new comment

The content of this field is kept private and will not be shown publicly.

More information about formatting options

What is 5 + 2?
To combat spam, please solve the math question above.