New HIV Drug Safe, Effective FDA Says
Posted by pozlife on September 1, 2007
by The Associated Press
Posted: August 31, 2007 – 5:00 pm ET
(Washington) A new HIV-fighting drug from Merck & Co. appears superior to options for patients who have stopped responding to available drugs, federal regulators said Friday.
The Food and Drug Administration said Merck’s studies of Isentress show the drug is safe and effective to treat HIV patients who have developed a resistance to other medications.
Roughly 1 million people in the U.S. are HIV positive, according to the Centers for Disease Control. FDA has cleared 30 different HIV treatments since 1987, and they are typically prescribed in combination to suppress the virus, which cripples the immune system and causes death if not treated.
The agency posted its review of the drug to the FDA Web site ahead of a Wednesday meeting, where outside experts are scheduled to vote on the drug’s safety and effectiveness. FDA is not required to follow the experts’ recommendations, though it usually does.
The agency granted the drug priority review status earlier this year, meaning staffers would finish the review in six months, four months earlier than usual. A decision is expected mid-October.
If approved, Isentress would be the first in a new class of HIV treatments called integrase inhibitors that block the virus from infecting cells and reproducing.
Government scientists said Isentress has a favorable safety profile, with rash and elevated levels of creatine in the blood reported as the most common side effects.
Merck reported 13 deaths among 900 patients who took Isentress in a clinical study although the FDA said the deaths were not related to the drug.
Isentress would compete with Pfizer’s Selzentry, another novel HIV treatment the FDA approved last month for drug-resistant HIV patients. Merck’s drug could be more attractive to doctors and patients because it appears to have fewer side effects.
Selzentry’s label carries a warning that the drug can cause liver damage and advises patients to see a doctor immediately if they develop an allergic reaction. FDA cleared the drug on the condition that the company conduct follow-up studies to look at the effects of long-term use.
On Wednesday, the FDA will ask its outside experts whether Merck should be required to conduct post-marketing studies on Isentress.
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