Merck Gets FDA Approval
For New HIV Treatment
By JENNIFER CORBETT DOOREN
October 12, 2007 5:50 p.m.
WASHINGTON -- A U.S. Food and Drug Administration panel Friday approved a new type of HIV drug from Merck & Co., a company spokeswoman said.
The drug, known by the brand name Isentress, was approved for use in patients who have failed treatment with other HIV drugs.
Isentress was approved as part of the FDA's accelerated-approval mechanism, which is aimed at getting life-saving treatments to market faster by allowing companies to submit less clinical data than usually required. Companies obtaining accelerated approval must keep studying drugs after they are on the market to gain full approval.
Isentress is designed to target one of three enzymes needed by HIV to reproduce. Current drugs on the market attack the other two enzymes, reverse transcriptase and protease. If approved, Isentress would be the only drug to target the third enzyme, known as integrase. Amy Rose, a Merck spokeswoman, said treatment with Isentress would cost about $9,850 a year.
Patients with HIV typically are treated with a "cocktail" of two or three types of drugs. However, over time, most HIV viruses mutate and stop responding to certain drugs, creating the need for new ones. Isentress is meant to be used in combination with other HIV drugs. |
