Bristol-Myers Squibb Co. and Gilead Sciences Inc. will sell the drug in the U.S. under the brand name Atripla. Merck & Co. will be involved in marketing the drug in countries outside the U.S.
Atripla is a tablet that would be taken once daily by adults with HIV infection, the virus that causes AIDS. The drug could be combined with other HIV/AIDS therapies, the FDA said. It was approved in less than three months as part of an agency program to more quickly bring life-saving medicines to the market.
The drug combines Bristol's Sustiva with Gilead's Emtriva and Viread. Merck holds the marketing rights to Sustiva outside the U.S., which it sells under the name Stocrin. The collaboration among the three companies is the first of its kind in the HIV/AIDS field.
The new combination drug -- which may be available starting next week -- would simplify treatment for HIV/AIDS by cutting down the number of medications patients must remember to take. It also has the potential to cut down on the emergence of drug-resistant HIV strains that develop more rapidly when patients forget to take some doses of their drugs
"This offers a particularly important advantage for patients in many countries that are most affected by the AIDS epidemic and will also have a major impact in the U.S.," said Andrew von Eschenbach, the acting FDA commissioner.
more recent approvals : http://chartsbank.com/PipelineList.aspx
No comments:
Post a Comment