NEW YORK A Food and Drug Administration advisory committee has recommended approval for an HIV drug as a first-line treatment for the disease.
Drug maker Pfizer announced Thursday that the FDA’s Antiviral Drugs Advisory Committee had voted 10 to 4 to recommend the approval for Selzentry (maraviroc) in combination with other drugs in adult patients who have not taken drugs for HIV before. The drug is already approved as a treatment for HIV patients who have not responded to other therapies.
“Pfizer is pleased that the committee has recognized the effectiveness and safety profile of maraviroc in patients who are starting HIV therapy,” Pfizer executive director and disease area leader for antiviral drugs Howard Mayer said in a statement.
Results of a clinical trial indicated that the drug, when combined with GlaxoSmithKline’s Combivir (zidovudine and lamivudine) was as effective as Bristol-Myers Squibb’s Sustiva (efavirenz) combined with Combivir in reducing viral load. In terms of safety, patients taking Selzentry and Combivir experienced less than half of the adverse side effects as those in the Sustiva group.
An FDA advisory committee’s recommendation does not guarantee final approval of a drug, but the FDA takes it into account when making a final decision.