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news.Pfizer has reported that the FDA has approved its Selzentry treatment for HIV, the first in a new class of oral HIV medicines in 10 years.
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Selzentry (maraviroc) blocks viral entry into white blood cells, significantly reducing viral load and increasing T-cell counts in treatment-experienced patients infected with a specific type of HIV.
The FDA granted accelerated approval to Selzentry for combination antiretroviral treatment of adults infected with only CCR5-tropic HIV-1 detectable, who have evidence of viral replication and have HIV-1 strains resistant to multiple antiretroviral agents. A diagnostic test confirms whether a patient is infected with CCR5-tropic HIV-1, which is also known as ‘R5 virus.’
An accelerated approval allows for earlier approval of drugs that provide a meaningful therapeutic advantage over existing treatment for serious or life-threatening diseases. This approval is based on 24-week data. Longer-term data will be required before the FDA can consider traditional approval for Selzentry.
Selzentry is expected to be available in the US by the middle of September.
Pfizer is currently submitting marketing applications around the world and recently received a positive opinion from the CHMP in the EU. Pfizer intends to commercialize the product with the name Celsentri outside of the US.