FDA Clears New Gilead HIV Drug - TheStreet

FDA Clears New Gilead HIV Drug

The agency gives the company clearance to start marketing Emtriva, a once-daily treatment.
Publish date:

Gilead Sciences

(GILD) - Get Report

said the Food and Drug Administration granted the company clearance to start marketing Emtriva, a once-daily treatment for HIV that's designed to be used in combination with other antiretroviral medications.

The company said Emtriva attacks HIV by inhibiting reverse transcriptase, the enzyme that copies HIV RNA into new viral DNA. By interfering with this process, Emtriva can help to lower the amount of HIV in a patient's body and increase the number of immune system cells.

Both of these changes are generally associated with improving a patient's health and decreasing the likelihood of AIDS-related illnesses, Gilead said.

Emtriva is Gilead's second once-daily antiretroviral for treating HIV. The compound was licensed from Emory University in 1996. Gilead's first anti-HIV medication, Viread, was approved by the FDA in October 2001. The company is developing a fixed-dose co-formulation of Emtriva and Viread, which could potentially be available by early 2005.

In the U.S., the wholesaler acquisition cost for Emtriva is $252.83 for a bottle of 30 capsules, or one month of therapy. The drug will be available and shipped to wholesalers in the next week.

Shares of Gilead were halted prior to the release of the news, and last traded at $56.39, up 2.5%, on the