Nycomed’s Daxas granted EU approval

Nycomed has been granted authorisation for its chronic obstructive pulmonary disease (COPD) treatment Daxas to be marketed in the EU.

The European Medicines Agency has given its approval to the new treatment on the basis of findings from four phase III clinical trials, which supported the efficacy of the drug as a therapy for symptomatic COPD.

Nycomed states that the once-daily oral tablet treatment is the first drug of its kind in a new class and will now commence the introduction of Daxas across Europe, beginning with the UK and Germany.

It will take responsibility for the manufacturing of the drug and will be assisted in its promotion by Merck Sharpe and Dohme in several territories, including the UK.

Guido Oelkers, executive vice-president of commercial operations at Nycomed, said: “The approval of Daxas offers clinicians and patients a much needed new treatment option alongside existing inhaled therapies.”

Nycomed previously expressed confidence in its first quarter financial report that the launch of Daxas will play a key role in driving sales growth in the coming months.