Nycomed and partner Forest Laboratories are celebrating this morning after regulators in the USA gave the thumbs-up to the chronic obstructive pulmonary disease drug roflumilast.
Specifically, the US Food and Drug Administration has approved Daliresp (roflumilast), marketed elsewhere as Daxas, as a treatment to reduce the risk of COPD exacerbations associated with chronic bronchitis. The once-daily oral drug is a selective phosphodiesterase-4 (PDE4) inhibitor approved and will be available to wholesalers in the second quarter.
The road to approval in the USA has not been particularly smooth. In May last year, the FDA issued the firms with a complete response letter and asked for “certain additional information and analyses of existing data”, though no new trials were requested. The initial rejection came after the FDA’s Pulmonary-Allergy Drugs Advisory Committee voted 10-5 against approval, which came as a surprise given that earlier the panel voted 9-6 that roflumilast 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 appeared to be safe.
Forest responded to the FDA's queries last September and the agency is now satisfied. COPD experts are very excited about the potential of roflumilast, which competes with Boehringer Ingelheim/Pfizer’s Spiriva (tiotropium), GlaxoSmithKline's Advair/Seretide (salmeterol/fluticasone) and AstraZeneca’s Symbicort (budesonide/formoterol).
The firms linked up on the drug in August 2009 and Guido Oelkers, head of commercial operations at Nycomed, said that in Forest "we have an ideal partner, who is absolutely committed to make this innovative treatment available in the USA for the many patients suffering from severe COPD". He added that the approval of Daliresp "offers clinicians and patients a much needed new treatment option alongside existing inhaled therapies".