New HIV Drug Receives Positive Response From FDA Advisory Panel

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Nidhi Sharma - AHN News Writer

Washington D.C. (AHN) - The Food and Drug Administration said Friday that a new experimental HIV-fighting drug from Merck and Co. appears to outweigh the "current identified" risks.

The federal announcement of Isentress comes ahead of a panel meeting next Wednesday that will recommend whether the drug should be approved.

Merck's studies of Isentress show the drug is safe and effective to treat HIV patients who have developed a resistance to other medications. If approved, the drug, known generically as raltegravir, would be the first in a new class of HIV medicines called integrase inhibitors that block the virus from infecting cells and reproducing.

According to announcement on FDA's website, the common side effects of the drug include a rash and elevated levels of creatine in the blood. No deaths in the clinical trial data could be linked to the drug, they wrote.

Currently, HIV patients are treated with two or three types of drugs. However, over time, most HIV viruses mutate and stop responding to the drugs, creating the need for new types of drugs.

According to the Centers for Disease Control, nearly 1 million people in the U.S. are HIV positive. The decision n drug's approval is expected mid-October.

If approved, Isentress is expected to compete with Pfizer's Selzentry, another new HIV drug that the FDA approved last month for drug-resistant HIV patients.