According to Nycomed, Roflumilast was reviewed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations. COPD is an under-diagnosed, progressive lung disease that is the fourth leading cause of death in the US.
In the CRL the FDA requested certain additional information and analyses. No additional patient trials have been requested for the continued review of the NDA. Nycomed and Forest are committed to working with the FDA to address the outstanding matters and the companies anticipate a response to the FDA during the third calendar quarter of 2010.
Nycomed said that Roflumilast is a phosphodiesterase 4 enzyme inhibitor that targets the underlying inflammation associated with COPD. If approved, roflumilast, a once-a-day oral tablet, will be the first in a new class of treatment for COPD. Roflumilast is not a steroid.
Will this CRL help Nycomed and Forest Laboratories?
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