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FDA Says ‘No’ to Two HIV Drugs

Agency cites deficiencies in quality testing (Apr. 29)

The FDA has declined to approve elvitegravir and cobicistat for use as part of human immunodeficiency virus (HIV) treatment regimens as standalone agents. Both drugs are manufactured by Gilead Sciences.

In its complete response letters (CRLs), the agency stated that it cannot approve the new drug applications (NDAs) in their current forms. The letters said that, during recent inspections, deficiencies in documentation and validation of certain quality testing procedures and methods were observed.

Elvitegravir and cobicistat are also components of Gilead’s once-daily HIV-1 drug Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), which was approved by the FDA in August 2012 for treatment-naïve adults. The new regulatory action does not affect the marketing authorization or continued use of Stribild.

NDAs for elvitegravir and cobicistat were submitted to the FDA in June 2012.

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.

Cobicistat is a mechanism-based inhibitor of cytochrome P450 3A (CYP3A), an enzyme that metabolizes drugs in the body. Unlike ritonavir, cobicistat acts only as a pharmaco-enhancing or “boosting” agent and has no antiviral activity.

Source: Gilead Sciences; April 29, 2013.

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