FDA approves Pfizer’s first-in-class HIV drug
pharmafile | August 8, 2007 | News story | Sales and Marketing |Â Â HIVÂ
Pfizer has won US approval for Selzentry, making it the first new class of oral HIV medicines to reach the market in more than 10 years.
Selzentry (maraviroc) works by blocking viral entry into white blood cells, rather than fighting the virus from the inside as all other oral HIV drug classes do.
This significantly reduces viral load and increases T-cell counts in treatment-experienced patients, but it is only effective in those patients infected with a specific type of HIV.
The FDA granted Selzentry accelerated approval for the combination antiretroviral treatment of adults infected with the CCR5-tropic HIV-1 strain, who have evidence of viral replication and have HIV-1 strains resistant to multiple antiretroviral agents.
Dr. Joseph Feczko, Pfizer's chief medical officer, said: "There is a profound need for new medicines to treat HIV. In the United States, thousands of patients living with HIV are running out of effective medications that can control their virus."
Selzentry's approval was based on 24-week data from the MOTIVATE trials. These showed that when Selzentry was used in combination with an optimised background therapy (OBT), when approximately twice as many patients achieved an undetectable viral load, compared to those on OBT alone.
Pfizer will be required to produce longer-term trial results before the FDA can consider a traditional approval.
The drug is due to be launched in the US in September, when its labelling will include warnings about liver toxicity and the possibility of heart attacks.
It recently received a positive opinion from advisors to the European regulator, where it will be marketed, as in all territories outside the US, as Celsentri.
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