Nebivolol Approval Could Come In Mid-2007, Forest Says
This article was originally published in The Pink Sheet Daily
Executive Summary
The firm is conducting small studies of short duration after meeting with FDA regarding a May 2005 “approvable” letter.
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Forest Labs' beta blocker nebivolol is projected to be approved for hypertension during the first half of fiscal 2008, the company said in a fourth quarter earnings call April 25. Fiscal 2008 for Forest, which ended its fiscal year 2006 March 31, begins April 1, 2007. While Forest has not given specifics regarding studies needed to complete the NDA, the firm said they are pharmacological in nature, small and of short duration. The studies could take three to six months to complete. The company has met with FDA to evaluate what additional work is needed to respond to a May "approvable" letter for nebivolol, the firm said. Forest suggested that nebivolol could offer a side effect advantage, especially in the area of fatigue, which is a reason many patients discontinue taking beta blockers. Without providing details on studies to differentiate the drug, the firm noted that its R&D budget includes an "extensive Phase IV program" for nebivolol. Forest also is on track to file a separate nebivolol NDA for a congestive heart failure indication in the second half of 2006. The company has said it plans to put just over half of its 2,800-person sales force behind nebivolol, which it licensed from Mylan in January (1 (Also see "Mylan Finds Its Way Out Of The Woods: Forest Signs Nebivolol Licensing Agreement" - Pink Sheet, 12 Jan, 2006.)). In January, Mylan said that it had already completed a study to address questions raised in the approvable letter. -Janet Aker |