Pfizer HIV Drug Approved

The FDA has approved Pfizer‘s Selzentry tablets, the first in a new class of oral HIV medicines in more than 10 years, according to the marketer. Selzentry 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. Selzentry is expected to be available in the U.S. by the middle of September.

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 the first in a class of drugs known as CCR5 antagonists, which block the CCR5 co-receptor, the virus’ predominant entry route into T-cells. Selzentry stops the R5 virus on the outside surface of the cells before it enters, rather than fighting the virus inside as do all other classes of oral HIV medicines.