EMEA's CHMP backs approval of Nycomed's Daxas; calls for revocation of MA for bufexamac due to high risk of contact allergies

Swiss drugmaker Nycomed today announced that it has received a positive opinion from the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP), recommending the approval of Daxas (roflumilast) in the European Union. The drug, which has recently gained a negative opinion from the US Food and Drug Administration for marketing partner Forest Labs (The Pharma Letter April 8), is a proprietary selective phosphodiesterase 4 (PDE4) enzyme inhibitor that has been developed by Nycomed for the treatment of COPD.

Daxas is recommended for maintenance treatment of severe COPD (FEV1 post-bronchodilator less than 50% predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as an add-on to bronchodilator treatment. With the granting of the marketing authorisation by the European Commission, Daxas, a once-a-day tablet, would become the first drug in a new class. Daxas is expected to be launched in the first European countries later this year.

Commenting on today's announcement, Anders Ullman, executive vice president R&D at Nycomed, said: 'Daxas is the first in a new class of oral agents to treat this life-threatening condition, offering clinicians and patients a much needed new treatment option alongside existing inhaled therapies.'