FDA Gives RTF to Gilead NDA

Gilead Sciences, Inc. received a “refuse to file” notification from the FDA regarding Gilead’s NDA 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.

The FDA requested additional information with respect to the Chemistry, Manufacturing and Controls (CMC) section of the Truvada/TMC278 NDA submission. The letter stated that the application does not contain sufficient information on the analytical methodology to establish acceptable levels of recently identified degradants related to emtricitabine.

“We are working to validate the methodology to resolve this issue and provide the required information to the FDA,” said Norbert Bischofberger, Ph.D., Gilead’s executive vice president, R&D and chief scientific officer. “We expect to be in a position to resubmit the Truvada/TMC278 NDA with the additional requested information prior to the end of the first quarter of this year.”

The FDA has the ability to formally file or refuse to file an application within 60 days of the completion of the submission, which occurred on November 23, 2010.