Sosei Group Corporation,Japan, has received a positive opinion for its Seebri Breezhaler (glycopyrronium bromide/NVA237),a type of bronchodilator, from European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP).
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.
