Gilead Sciences Inc. (GILD) said Monday the U.S. Food and Drug Administration has rejected its New Drug Applications for two HIV drugs, elvitegravir and cobicistat.
citing recent inspections, the FDA in its Complete Response Letters said deficiencies in documentation and validation of certain quality testing procedures were observed, thus resulting in the drugs' rejection.
Gilead indicated working with the Agency to address concerns and move the applications forward. Gilead submitted its NDAs for elvitegravir and cobicistat in June 2012 as stand alone treatments for HIV.
Elvitegravir and cobicistat are also components of Gilead's once-daily single tablet HIV-1 regimen Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg). Stribild was approved by FDA last August for treatment-naive adults.
The FDA rejection of elvitegravir and cobicistat does not affect the marketing authorization or continued use of Stribild, Gilead clarified.
Elvitegravir is a member of the integrase inhibitor class of antiretroviral compounds. Integrase inhibitors block the ability of HIV to integrate into the genetic material of human cells. Gilead licensed the drug from Japan Tobacco Inc. in March 2005 and the company has exclusive rights to develop and commercialize it in all countries of the world, except Japan.
Cobicistat is Gilead's proprietary potent mechanism-based inhibitor of cytochrome P450 3A, an enzyme that metabolizes drugs in the body.
Marketing applications for the two drugs are also pending in Europe.
Gilead is trading at $51.22, down 0.31%, on a volume of 7.4 million shares on the Nasdaq.
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