Nycomed’s Daxas approved in Europe for COPD

Nycomed is celebrating the news that regulators have given the green light to the chronic obstructive pulmonary disease drug Daxas.

The European Commission has granted marketing authorisation for Daxas (roflumilast), a novel oral, once-daily phosphodiesterase 4 enzyme inhibitor. It is indicated for maintenance treatment of severe COPD associated with chronic bronchitis in adults with a history of frequent exacerbations as an add-on to bronchodilator treatment.

The approval is based on results from four Phase III trials,including two 12-month studies involvingover 3,000 COPD patients, which demonstrate Daxas’ effectiveness on exacerbation rates and pulmonary function. The tablet is expected to be launched soon, starting in Germany and the UK and will compete with Boehringer Ingelheim/Pfizer’s Spiriva (tiotropium), GlaxoSmithKline's Advair/Seretide (salmeterol and fluticasone) and AstraZeneca’s Symbicort (budesonide/formoterol). In April, Nycomed signed up Merck Sharp and Dohme to co-promote Daxas in France, Germany, Italy, Spain and Portugal.

Daxas is the first new class of treatment for COPD in more than a decade and Nycomed quoted Neil Barnes, professor of respiratory medicine at Barts and the London Hospital, as saying that for patients with the disease “associated with chronic bronchitis and a history of flare ups, Daxas can make a real contribution.”

The European pathway to approval has run smoother than in the USA where Nycomed and partner Forest Laboratories received a complete response letter from the Food and Drug Admnistration in May.