Gilead Sciences Inc. (GILD: Quote) said Monday that the U.S. Food and Drug Administration has approved Stribild as a new once-daily single-tablet regimen for HIV-1 infection in treatment-naive adults.
The FDA approval places Stribild as the only once-daily, single-tablet regimen containing an integrase inhibitor, which unlike other classes of antiretroviral drugs, interfere with HIV replication by blocking the ability of the virus to integrate into the genetic material of human cells.
With Stribild, Gilead now has three single-tablet HIV regimen in its fold, and reflects the company's focus on simplification of antiretroviral therapy. Atripla, approved in 2006, and Complera, approved in 2011, are the other two single-tablet HIV regimens.
Stribild contains Gilead's two investigational drugs - Elvitegravir, which is an integrase inhibitor, and Cobicistat, a boosting agent, in combination with Truvada (Emtricitabine and Tenofovir disoproxil fumarate).
In phase III studies, Stribild showed comparable efficacy with Atripla and ritonavir-boosted atazanavir plus Truvada in achieving viral suppression and increasing CD4 cell counts after 24 and 48 weeks. The FDA nod for Stribild comes after a panel in May favored its approval.
Common side effects for Stribild include nausea and diarrhea, while serious effects include new or worsening kidney problems, decreased bone mineral density, fat redistribution and changes in the immune system. Stribild also has boxed warnings of lactic acidosis/severe hepatomegaly with steatosis and post treatment acute exacerbation of hepatitis B.
Gilead is required to conduct additional studies to help further characterize Stribild's safety in women and children, how resistance develops to the drug, and the possibility of interactions between Stribild and other drugs.
Applications for marketing approval of Stribild are also pending in Australia, Canada and the European Union. In the developing world, Gilead has granted multiple Indian manufacturing partners and the Medicines Patent Pool the right to develop generic versions of Stribild and distribute them to 100 developing countries.
Gilead has also had submitted the new drug application for Stribild's components - Elvitegravir and Cobicistat in June this year. The company has also made regulatory filings for Elvitegravir and Cobicistat in Europe.
HIV drugs namely, Atripla, Truvada, Viread, Complera and Emtriva account for a major chunk - making up 85 to 86 percent of Gilead's total revenue. In the second quarter 2012, Gilead's HIV franchise sales were up 15 percent to $1.986 billion.
GILD closed Monday at $57.19, down 0.17%, on the Nasdaq. In after hours, the stock gained $0.41 or 0.72%.
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by RTT Staff Writer
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