Further delay in US approval for Forest Labs/Nycomed's Daxas, but no additional clinical trials requested by FDA

There was disappointment for independent Swiss drugmaker Nycomed and its US partner Forest Laboratories yesterday, after the US Food and Drug Administration issued a complete response letter regarding the New Drug Application for Daxas (roflumilast), a selective phosphodiesterase 4 (PDE4) enzyme inhibitor being reviewed as a potential treatment to reduce chronic obstructive pulmonary disease (COPD) exacerbations associated with chronic bronchitis in patients at risk for exacerbations.

In the complete response letter the FDA requested certain additional information and analyses. However, the companies emphasized that the agency had not called for further patient trials for the continued review of the NDA. Nycomed and Forest say they are committed to working with the FDA to address the outstanding matters and anticipate a response to the agency during the third calendar quarter of 2010.

The decision probably comes as no surprise, since an FDA panel of external experts last month voted against approval of Daxas (The Pharma Letter April 8). The drug was licensed for US development by Nycomed in a deal which included an upfront payment of $100 million, plus milestones and royalties to the Swiss firm (TPL August 11, 2009).