Business In Brief

Executive Summary

CHMP recommends approval of Nycomed's Daxas: Nycomed's chronic obstructive pulmonary disorder therapy Daxas (roflumilast) received a recommendation for approval from the European Medicines Agency's Committee for Medicinal Products for Human Use, the company announced April 23. Daxas is recommended for maintenance treatment of severe COPD (FEV1 post-bronchodilator less than 50 percent predicted) associated with chronic bronchitis in adult patients with a history of frequent exacerbations as an add-on to bronchodilator treatment. CHMP is all but tantamount to full EU approval and Nycomed expects to launch the drug later this year. If Daxas gains marketing authorization there, it would be the first in a new class of oral agents for COPD. The drug is not faring as well in the U.S., however. On April 7, FDA's Pulmonary-Allergy Drugs Advisory Committee recommended against approval of Daxas (1"The Pink Sheet" DAILY, April 7, 2010)