FDA Panel to Consider Pfizer's Second-Line HIV Drug
February 9, 2007
On April 24, the Food and Drug Administration's antiviral drugs advisory panel will review maraviroc, a new CCR5 antagonist candidate made by Pfizer. The agency said Thursday its panel will evaluate the twice-daily pill's safety and efficacy data.
CCR5 antagonists block HIV from entering white blood cells through a pathway found in most patients with the virus. Pfizer will administer the drug along with a test made by Monogram Biosciences Inc. that evaluates whether patients are likely to respond to the treatment.
Rival drug companies are also developing second-line HIV drugs, these are typically for use by highly treatment-experienced patients with drug-resistant virus. However, UK-based GlaxoSmithKline stopped development of its candidate aplaviroc in 2005 after some patients developed signs of liver damage. At Schering-Plough Corp., mid-stage trials of a new second-line candidate are continuing, though the company reported some patients developed lymphomas.
Pfizer reports its trials of maraviroc have gone smoothly so far.
02.08.2007; Matthew Perrone
Maraviroc + OBT Potent in Treatment-Experienced HIV-Infected Patients: An Interview With Roy Gulick, M.D.
This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.