FDA scientists consider HIV treatment safe as first-line treatment
WASHINGTON A drug made by Pfizer for treating HIV is safe for patients who have not taken other drugs, according to briefing documents posted online Tuesday by the Food and Drug Administration.
Scientists at the FDA appear to favor approval for the new use of Selzentry (maraviroc), currently approved as a second-line treatment for HIV patients.
On Thursday, the briefing information will go before the FDA’s Antiviral Drugs Advisory Committee, which will decide whether or not to recommend approval. Advisory committees’ recommendations do not guarantee approval or rejection of a regulatory application, but they are taken into consideration when the FDA makes its final decision.