FDA rejects Forest/Nycomed's COPD drug roflumilast

Forest Laboratories and Nycomed have received some more disappointing news from US regulators who have asked for more information on their chronic obstructive pulmonary disease drug Daxas.

The US Food and Drug Administration has issued the firms with a complete response letter regarding the New Drug Application for Daxas (roflumilast) which was reviewed as a potential treatment to reduce COPD exacerbations associated with chronic bronchitis in patients at risk for exacerbations. In the letter, the agency has asked for “certain additional information and analyses” but “no additional patient trials have been requested”.

The decision is no great surprise seeing as how the FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 10-5 against approval of Daxas, an oral once-daily phosphodiesterase 4 enzyme inhibitor, in April. That vote came as a bit of a surprise given that earlier the panel voted 9 to 6 that Daxas is effective as a maintenance treatment for COPD, despite FDA staff documents having described the drug's benefit as modest. The committee also voted 9-6 that the drug appears to be safe.

Forest, which licensed the drug from Nycomed in August last year in a deal that could be worth around $600 million to the privately-owned Swiss firm, said it is committed to working with the FDA “to address the outstanding matters and the companies anticipate a response” during the third quarter of 2010.

The treatment is faring better in Europe, where the Committee for Medicinal Products for Human Use adopted a positive opinion on Daxas last month. That was swiftly followed by Nycomed signing a co-marketing deal with Merck & Co for roflumilast in certain European countries and Canada.