FDA gives priority review status to Gilead combination drug

The Food and Drug Administration on Monday announced that it has granted priority review status to a New Drug Application for a coformulation of Gilead Science's nucleoside reverse transcriptase inhibitor Emtriva and its nucleotide reverse transcriptase inhibitor Viread. Gilead submitted an application to the FDA on March 12 for its single pill that combines the two anti-HIV medications, each of which already has received separate FDA approval. The priority review status will ensure that the combination pill is reviewed within six months of its submission date. "The FDA's commitment to expedited review of new therapies and fixed-dose combinations for HIV/AIDS will help us continue to deliver important new medicines to help fight this disease," said Gilead president and CEO John Martin. "We believe this potential product represents an important advancement, and if approved, we will work to rapidly make the fixed-dose combination available to physicians and their patients." The FDA announcement came one day after Health and Human Services secretary Tommy Thompson announced that the FDA would streamline its drug approval process for anti-HIV medications so that generic drugs and combination pills could be more quickly approved for use in the five-year, $15 billion President's Emergency Plan for AIDS Relief that aims to help HIV-positive people in Africa and the Caribbean. Gilead also announced on Sunday that the company is working with drugmakers Bristol-Myers Squibb and Merck to develop a once-daily pill that contains a full day's dose of Viread, Emtriva, and the nonnucleoside reverse transcriptase inhibitor Sustiva, marketed jointly by BMS and Merck.