WASHINGTON (AP) -- 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 medica .
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.
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