Gilead Sciences Inc. said the Food and Drug Administration (FDA) has granted priority review of a fixed-dose combination HIV drug containing Emtriva and Viread. The announcement follows a joint statement made by Gilead, Bristol-Myers Squibb, and Merck that they were in
talks to develop a combination of three AIDS drugs. US officials have urged drug companies to provide better treatment options in developing countries. The companies said the pill would also include efavirenz, which is marketed by Bristol-Myers as Sustiva and by Merck as Stocrin.
> Gilead said it submitted the New Drug Application (NDA) to FDA on March 12 and had anticipated a decision by January 12, 2005, based on a customary 10-month waiting period. But under priority review, the NDA could be decided by September 12, 2004. According to
FDA policies, a priority designation is granted to drugs that address an unmet medical need, offering a significant improvement in the safety or effectiveness of treatment, diagnosis or prevention of a serious or life-threatening disease. The fixed-dose drug proposed will contain 300
mg of Viread and 200 mg of Emtriva and will be administered in combination with at least one other anti-HIV product.
Advertise with us
Subscriptions
Contact us
Site map
Translate
