Gilead Says FDA Won't Accept Filing for AIDS Pill

The Food and Drug Administration wants additional information on Gilead Sciences Inc.'s proposed once-daily AIDS drug combination, the drug maker said. FDA had originally agreed to complete a priority review of the combination, Gilead's Truvada with Johnson & Johnson's (J&J) experimental drug TMC278, in six months. Since FDA decided not to accept the application, the clock is not ticking, said Norbert Bischofberger, Gilead's executive vice president for research and development and chief scientific officer.

FDA wants more details on the chemistry and manufacturing of the combination treatment. During testing of the proposed drug, Gilead discovered a "degradation product" was present in the medicine at a level that requires evaluation, the drugmaker said. "The impurities have to be qualified to be sure they don't pose a risk," said Bischofberger.

Gilead said it will give FDA the requested information by the end of March. "I am confident this will result in only a minor delay in bringing this important new treatment to patients," said John Martin, Gilead's CEO.

Tibotec, a unit of J&J, submitted a marketing application to FDA for TMC278 following the completion of two large clinical trials. According to Gilead, the application for Truvada-TMC278 is supported by a bioequivalence study showing the drugs combined reached the same levels in the bloodstream as each drug separately.

The combination drug could attract patients seeking to avoid the side effects of Gilead's Atripla, which includes Bristol-Myers Squibb Co.'s Sustiva. Data presented at the July International AIDS Conference in Vienna showed TMC278 suppressed HIV as well as Sustiva, said Michael Saag of the University of Alabama-Birmingham. That study also showed that Sustiva kept 4.8 percent of patients' viruses from rebounding, compared to 9 percent for TMC278.

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