Yesterday’s Federal Register carried a notice for meeting on Ketek held by the Anti-Infective Drug Advisory Committee to be held jointly with the Drug Safety and Risk Management Committee. It will be held held on December 14, 2006, from 8 a.m. to 6 p.m. and on December 15, 2006, from 8 a.m. to 5 p.m.
According to the notice, "on both days, the committee will discuss the overall benefit to risk considerations for the approved product KETEK (telithromycin), new drug application (NDA) 21-144, with the current indications of: Acute bacterial exacerbations of chronic bronchitis, acute bacterial sinusitis, and community acquired pneumonia, manufactured by Sanofi-Aventis."
The questions that the FDA will be asking the committee probably won’t be available until about 24 hours before the meeting. Two days is an extraordinary amount of time to cover issues related to a single drug. When the entire set of COX-2s were examined, the meeting took three days, but covered several drugs.
In any case, the fact that the meeting is occurring may not be good news for Ketek fans. Meetings of this sort foreshadows new risk management measures, and possible departure from the market, as in the case of Rezulin – a diabetes drug that had new risk management procedures attached to its use after such a meeting and then was eventually pulled from the market. Until we see the questions the FDA poses to the committee, the outlook may be murky.