Data from three of the Novartis Phase III GLOW trials, which included 1,996 COPD patients, announced the CHMP’s positive opinion for Seebri Breezhaler .
Seebri Breezhaler was well tolerated with a trace of adverse events similar to placebo in all studies.
The drug is a long-acting muscarinic antagonist (LAMA) used in the treament of chronic obstructive pulmonary disease (COPD).
Sosei CEO Shinichi Tamura said,"The drug was developed to Phase II proof-of-principle by the two companies before being licensed to Novartis and, when approved, will be the second once-daily inhaled treatment in the LAMA class for COPD patients.”
The US filing for Seebri Breezhaler is expected in 2014.