Merck's AIDS Drug Gets FDA Staff Support
Benefits of an experimental AIDS drug developed by Merck & Co appear to outweigh risks, according to U.S. Food and Drug Administration staff documents released Friday ahead of an advisory panel meeting.
FDA staff said they support the safety and effectiveness data of the pill, called Isentress, according to documents posted on the agency's Web site. A panel of FDA advisors will meet Sept. 5 to review Merck's bid and make a recommendation.
Isentress, known generically as raltegravir, was tested in patients who have become resistant to currently available HIV medicines. If approved, it 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.
FDA staff said the most common side effects occurring in the Isentress group were rash and an increase in levels of blood creatine.
No deaths in the clinical trial data could be linked to the drug, they wrote.
Because of advances in treatment, more people are living with HIV or AIDS than ever before. From 2001 to 2005, the numbers of those living AIDS in the United States rose 27 percent to about 422,000 people, according to the Centers for Disease Control and Prevention.