Impact of FDA OK for Merck & Co's Isentress

The approval by the US Food and Drug Administration of drug major Merck & Co's Isentress (raltegravir), the first integrase inhibitor drug which blocks the ability of the HIV virus to replicate and infect new cells, is likely to have an important impact on the sector, says Sylvia Eash, an analysts at market research group Decision Resources.

Integrase inhibitors are a novel class of HIV drugs aimed at a previously-unexploited viral target. They are a key new group that will expand therapeutic options for HIV patients and stand out as one of the most promising emerging classes in development for HIV. The reported efficacy and safety data from clinical trials of Isentress indicate that the product is highly efficacious, safe, well tolerated in both treatment-naive and treatment-experienced HIV patients. The clinical data on Isentress presented to date suggests that there is significant opportunity for follow-on agents in this new class of HIV drugs.

Isentress is expected to launch during the fourth quarter of 2007, according to Merck.