FDA: Merck HIV Drug Data Solid

The Food and Drug Administration released a brief pre-empting an advisory meeting on Merck's(MRK Quote) HIV treatment Isentress that supported the drugmaker's findings and could predict a positive recommendation of the drug.

Isentress, known generically as raltegravir, is the first in a new class of antiretroviral agents known as integrase inhibitors to be submitted for FDA approval. They work by blocking an enzyme necessary for replication of the virus from being integrated into the subject's DNA.

The review team said that the FDA's analyses of the safety and efficacy data submitted in the new-drug application (NDA) support Merck's findings for patients who had stopped responding to other treatments. Specifically, phase II and phase III data "provide evidence that the antiviral activity of raltegravir is superior to optimized background therapy (OBT) in treatment-experienced patients with few or no remaining treatment options," the team wrote in its review. ...