FDA has given Pfizer the go-ahead for its first-in-class HIV medication, maraviroc. The company expects that the drug, which will be sold under the trade name Selzentry, will be available in the U.S. by the middle of September.
After receiving a unanimous vote of support from an FDA advisory committee in April, the agency stalled by sending Pfizer an approvable letter in June. The final sanction of the drug drove Pfizer’s shares up 60 cents, or 2.6%, to $24.11 at 4:01 p.m. in New York Stock Exchange composite trading.
Pfizer is awaiting approval from the EMEA and is submitting marketing applications to other regulatory bodies. On June 20, an EMEA advisory committee vouched in favor of maraviroc, which will be sold in the EU as Celsentri.
Rather than fighting HIV inside white blood cells, maraviroc prevents the virus from entering uninfected cells by blocking the predominant route of entry, the CCR5 co-receptor. Among patients who have previously received HIV medications, approximately 50% to 60% have circulating CCR5-tropic HIV-1, according to the FDA.
The agency granted accelerated approval to Selzentry in combination with other antiretroviral drugs in adults with CCR5-tropic HIV-1 who have been treated with other HIV medications and who have evidence of elevated levels of HIV in their blood. A diagnostic test is required to confirm whether a patient is infected with CCR5-tropic HIV-1, which is also known as R5 virus.
Longer-term data will be required before the FDA can consider traditional approval for Selzentry, Pfizer notes.