Merck & Co. reports that an FDA advisory panel unanimously recommended accelerated approval of its HIV drug. The company anticipates the agency to make a decision by mid-October.
If approved, Isentress™ , in combination with other antiretroviral therapy will be administered to treatment-experienced patients with ongoing viral replication despite existing therapy.
Isentress could become the first in a new class of antiretroviral agents called integrase inhibitors. While current drugs act on protease and reverse transcriptase enzymes, Isentress inhibits the integrase enzyme. It thus prevents the insertion of HIV DNA into human DNA, blocking the ability of the virus to replicate and infect new cells, Merck explains.
Merck is also preparing regulatory filings in countries outside the U.S.