US FDA finally approves Nycomed/Forest's COPD therapy roflumilast

The US Food and Drug Administration has approved independent Swiss drugmaker Nycomed and US partner Forest Laboratories’ (NYSE: FRX) Daliresp (roflumilast; marketed as Daxas outside the USA) as a treatment to reduce the risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Daliresp is the first and only selective phosphodiesterase-4 (PDE4) inhibitor approved in the USA and is an oral tablet taken once daily. While the specific mechanism by which the drug exerts its therapeutic action in COPD patients is not well defined, it is thought to be related to the effects of increased intracellular cyclic AMP in lung cells. Forest expects Daliresp to be available to wholesalers in the second calendar quarter of 2011.

Up to $500 million sales projected