The Japanese Ministry of Health, Labor and Welfare (MHLW) has approved Novartis’s Seebri glycopyrronium bromide inhalation capsules, delivered by the Breezhaler DPI, for the treatment of COPD. The product should be available in Japan by the end of 2012.
The glycopyrronium inhalation formulation was co-developed by Sosei and Vectura, which licensed it to Novartis in 2005, and the Japanese agency is the first to approve it. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of glycopyrronium in June of this year, and EU approval is expected by the end of 2012.
Sosei CEO Shinichi Tamura commented, “We are delighted with the MHLW approval of Seebri inhalation capsules which marks an important milestone in the evolution of the Sosei business.”
Vectura Chief Executive Chris Blackwell said, “The approval of Seebri inhalation capsules in Japan is an important event for Vectura, triggering a $2.5 million milestone and further validation of our late stage respiratory platform. Seebri inhalation capsules provides doctors and patients with a much needed, once-daily, treatment option for COPD, a condition that can lead to death and is increasing in prevalence in Japan and worldwide.”
Read the Vectura press release.
Read the Sosei press release.
