Pfizer to Launch New HIV Treatment Selzentry in Mid-September

Pfizer will launch its first-in-class HIV treatment Selzentry in mid-September, the company announced.

The FDA approved Selzentry (maraviroc), a CCR5 co-receptor antagonist, Aug. 6 for the treatment of adults infected with detectable CCR5-tropic HIV-1 when there is evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.

The approval follows the issuance of an FDA approvable letter for the drug in June and a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use last month.

Although the approved indication recommends use only for patients with detectable CCR5-tropic HIV-1 who have previously received HIV medications, approximately 50 to 60 percent have circulating CCR5-tropic HIV-1, according to the FDA.

Physician labeling for Selzentry carries a black box warning for hepatotoxicity, or chemically induced liver failure. In addition, the warnings and precautions section of the labeling states that cardiovascular adverse events, including postural hypotension and myocardial ischemia and/or infarction, occurred during clinical trials, although generally only in subjects with cardiac disease or risk factors.

The approval is a victory for firms looking to develop CCR5 antagonists, as safety issues have plagued their development. GlaxoSmithKline (GSK) halted development of its CCR5 antagonist aplaviroc in 2005 because of cases of severe hepatotoxicity observed in Phase II and III trials.