Shortly after announcing a co-promotion deal with Eisai for its inhaled COPD drugs in Japan, Novartis has filed a new drug application in that country for one of those drugs, NVA237 inhaled glycopyrronium bromide, according to Vectura, which licensed the drug to Novartis.
Vectura CEO Chris Blackwell remarked, “The Japanese market is a large and growing market with an estimated 5 million people in Japan suffering from COPD. The filing of NVA237 in Japan therefore represents an important milestone for us ahead of an anticipated approval and launch of NVA237 in Europe over the course of the next 12 months.”
Novartis filed an MAA for NVA237 in Europe in September; in the US, the FDA has asked for additional data to support the NDA.
Read the Vectura press release.
