Apr 29, 2013
By Toni Clarke
WASHINGTON (Reuters) Apr 29 - Gilead Sciences Inc said on Monday that U.S. health regulators rejected two of its HIV drugs as standalone therapies, citing deficiencies in documentation and validation of certain quality testing procedures.
The company is seeking approval for its integrase inhibitor elvitegravir for people with HIV who have already been treated with other products.
Gilead is also seeking approval of cobicistat, a drug that does not itself fight the virus but boosts the function of other HIV medicines.
Both drugs are already contained in Gilead's once-daily single-tablet HIV treatment Stribild, which combines four different medications and was approved in the United States last August.
Stribild contains elvitegravir, cobicistat, emtricitabine and tenofovir disoproxil fumarate.
Gilead said it is working with the U.S. Food and Drug Administration to address the questions raised in the rejection letter in order to move the application forward.
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