FDA statement on Merck’s AIDS Drug, Isentress

MerckWashington: The U.S. Food and Drug Administration staff documents released on Friday has sustained that the benefits of an experimental AIDS drug developed by Merck & Co appear to overshadow risks.

The documents posted on the agency's Web site articulate that the FDA staff endorses the safety and effectiveness data of the pill, called Isentress. On Sept. 5, a panel of FDA advisors will meet to review the Merck’s bid and for recommendation.

Generically as raltegravir, Isentress was tested in patients who have become resistant to currently available HIV medicines. If approved, the drug would be the first in a new class of HIV medicines called integrase inhibitors which aim to block insertion of HIV genetic material into human DNA to prevent replication of the virus.

According to the agency, the most common side effects associated with Isentress were rash and a growth in levels of blood creatine, and no deaths in the clinical trial data could be linked to the drug.