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Evaluation Resumes for Gilead's Rilpivirine/Truvada Single-tablet

SUMMARY: Gilead Sciences announced this week that the company has re-filed a New Drug Application (NDA) for its single-tablet antiretroviral regimen containing the investigational non-nucleoside reverse transcriptase inhibitor (NNRTI) rilpivirine (TMC278) plus tenofovir/emtricitabine (the drugs in the Truvada pill). In July the U.S. Food and Drug Administration (FDA) declined to accept the NDA pending further information about manufacturing and testing, but has now determined that the approval process may move forward.

Below is an edited excerpt from a Gilead press release describing the new filing.

Gilead Sciences Refiles New Drug Application with the FDA for Single-Tablet Regimen of Truvada and TMC278

Foster City, Calif. -- February 10, 2011 -- Gilead Sciences, Inc. (Nasdaq:GILD) announced today that it has refiled a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for the single-tablet regimen of Truvada (emtricitabine and tenofovir disoproxil fumarate) and Tibotec Pharmaceuticals' investigational non-nucleoside reverse transcriptase inhibitor TMC278 (rilpivirine hydrochloride) for HIV-1 infection in adults.

Gilead previously submitted an NDA for the single-tablet regimen of Truvada/TMC278 on November 23, 2010. The company announced on January 25, 2011 that it had received a "refuse to file" notification from the FDA regarding that submission. Specifically, the FDA requested additional information on the analytical methodology and qualification data used to establish acceptable levels of recently identified degradants related to emtricitabine; this information has been included in the refiling.

The FDA has up to 60 days to conduct a preliminary review to assess whether the NDA is sufficiently complete to permit a substantive review. The FDA will establish a target action date for the NDA, under the Prescription Drug User Fee Act (PDUFA), if the application is formally filed.

About Gilead

Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company's mission is to advance the care of patients suffering from life-threatening diseases worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
For more information, see www.gilead.com.

2/18/11

Source
Gilead Sciences. Gilead Sciences Refiles New Drug Application with the FDA for Single-Tablet Regimen of Truvada and TMC278. Press release. February 10, 2011.

 


 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 


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