As expected, the European Commission has approved Novartis’s Seebri Breezhaler glycopyrronium bromide DPI for the treatment of COPD. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) issued a positive recommendation for glycopyrronium in June 2012. The announcement comes just days after the announcement of the approval of Seebri inhalation capsules in Japan.
Chris Blackwell, Chief Executive of co-developer Vectura, said, “The approval of Seebri Breezhaler in Europe is an important development in providing access to new treatment options for patients with COPD. This innovative, once-daily therapy has the potential to reduce breathlessness and exacerbations, improve lung function and help improve overall quality of life.”
The approval triggers $10 million milestone payments to Vectura and its development partner Sosei. Novartis licensed the product in 2005.
Read the Vectura press release.
Read the Sosei press release.
