US FDA delays approval of Gilead's elvitegravir and cobicistat for HIV

US antiviral drug specialists Gilead Sciences (Nasdaq: GILD) says it has received Complete Response Letters from the US Food and Drug Administration for its New Drug Applications for elvitegravir and cobicistat for use as part of HIV treatment regimens. Gilead’s shares, which have almost doubled in the past 12 months, dipped less than 1% to $51.09 by close of New York trading yesterday (April 29) following the announcement.

In its communications, the FDA states that it cannot approve the applications in their current forms. The letters note that, during recent inspections, deficiencies in documentation and validation of certain quality testing procedures and methods were observed. Gilead is working with the FDA to address the questions raised in the CRL and move the applications forward.

Elvitegravir and cobicistat are also components of Gilead's once-daily single tablet HIV-1 regimen Stribild (elvitegravir 150mg/cobicistat 150mg/emtricitabine 200g/tenofovir disoproxil fumarate 300mg), which was approved by the FDA last year (The Pharma Letter August 22, 2012, for treatment-naive adults. This regulatory action does not affect the marketing authorization or continued use of Stribild, the company said.