Gilead Sciences Inc. (GILD) announced Monday that it has received Complete Response Letters from the U.S. Food and Drug Administration for its New Drug Applications or NDAs for elvitegravir and cobicistat for use as part of HIV treatment regimens.
In the letters, FDA stated that it cannot approve the applications in their current forms. The letters also stated that during recent inspections, deficiencies in documentation and validation of certain quality testing procedures and methods were observed.
The company noted that it is working with FDA to address the questions raised in the Complete Response Letters and move the applications forward.
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), which was approved by FDA in August 2012 for treatment-naïve adults.
The company said that the regulatory action does not affect the marketing authorization or continued use of Stribild.
The company submitted its NDAs for elvitegravir and cobicistat in June 2012. Marketing applications are also pending in Europe.
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. Elvitegravir was licensed by Gilead from Japan Tobacco Inc. in March 2005. As per the terms of Gilead's deal with JT, Gilead has exclusive rights to develop and commercialize elvitegravir in all countries of the world, excluding Japan, where JT retains rights.
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