Pfizer announces FDA recommendation for Selzentry

Pfizer has announced that the Antiviral Drugs Advisory Committee of the Food and Drug Administration (FDA) voted ten to four to recommend the approval of Selzentry (maraviroc) tablets for use in treatment-naive adult patients with the CCR5-tropic HIV-1 virus, as part of combination therapy.

The committee viewed the results of a 48-week phase III trial into the drug as part of its evaluation.

Accelerated approval for the product was granted in 2007, with full approval following in November 2008 for the drug’s use in treatment-experienced adult patients with only CCR5-tropic HIV-1 virus in combination with other antiretroviral therapies.

Doctor Howard Mayer, executive director and disease area leader of antivirals at Pfizer, said: “Today’s discussion marks an important step in expanding available treatment options for patients with HIV infection and we look forward to working with the FDA to further address the points raised.”

Meanwhile, it was revealed last month that Pfizer and Eisai have resolved contentious issues that arose during a partnership related to the Alzheimer’s disease treatment Aricept (donepezil hydrochloride).