FDA has approved Nycomed and partner Forest Laboratories’ Daliresp™ (roflumilast) for use in reducing risk of chronic obstructive pulmonary disease (COPD) exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations. The firms claim the once-daily oral drug is the first selective phosphodiesterase-4 (PDE4) inhibitor to be approved in the U.S. Roflumilast was approved in the EU and Canada in 2010, where it is marketed under the brand name Daxas®. Roll out across approved territories has been initiated. Forest negotiated a U.S. license to the drug from Nycomed in 2009.
“Nycomed is very pleased with the U.S. approval of Daliresp by the FDA,” remarks Guido Oelkers, executive vp for commercial operations at Nycomed. “With Forest we have an ideal partner...the approval of Daliresp offers clinicians and patients a much needed new treatment option alongside existing inhaled therapies.”
Daliresp’s mechanism of action has not been well defined, but is believed to involve increasing intracellular cyclic AMP in lung cells, Forest and Nycomed point out. The development program for the drug included eight clinical trials involving 9,394 adults. Four large randomized placebo controlled trials showed that roflumilast significantly reduces exacerbations and improves lung function when added to first-line maintenance therapy, Nycomed notes.
Forest says FDA clearance was based on two one-year exacerbation studies involving over 3,000 patients already being treated using long-acting beta-agonists and short-acting antimuscarinics. The studies showed that in comparison with placebo, additional Daliresp therapy reduced the rate of moderate to severe exacerbations by 15–18%.