"After receiving an Approvable letter in June from the FDA on our NDA for NEBIDO, we began planning the course toward resubmission to address FDA's concerns about the quantification of the incidence of serious cough reactions in clinical trials. The NDA contained a single, serious cough reaction in approximately 4,000 injections of NEBIDO. In September, we reached agreement with FDA that submitting additional safety data from ongoing clinical trials in Europe would be appropriate and sufficient to address their concerns. The new data include the results from approximately 10,000 additional injections in Phase IV trials conducted by our partner, Bayer Schering Pharma AG, Germany. The data from these trials has been collected and we believe that there have been no additional cases of serious cough reaction implying an incidence of approximately 1 in 14,000 injections which we believe confirms the rarity of the adverse event. We expect to re-file the NDA by the end of the first calendar quarter of 2009, and FDA will have six months to review the NDA.
"We continue to see strong performance and positive trends for VANTAS(R) (prostate cancer) and SUPPRELIN(R) LA (central precocious puberty). Sales of VANTAS units in the fourth quarter were up 70% over the fourth quarter last year, and we are encouraged by the trends in the first quarter. VANTAS is the only once-yearly treatment in the market and our sales force has done a terrific job of demonstrating the benefits of a long acting product," continued Dr. Cooper.
"Adoption of SUPPRELIN LA in the treatment of central precocious puberty
|SOURCE Indevus Pharmaceuticals, Inc.|
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