Novartis Pharma has registered a new drug application (NDA) for NVA237 (glycopyrronium bromide) in Japan.
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NVA237 is a long-acting muscarinic antagonist (LAMA) used to treat adult patients with chronic obstructive pulmonary disease (COPD).
In April 2005, Novartis licensed the drug from Japan’s Sosei and UK – based Vectura.
Vectura chief executive Chris Blackwell said the filing of NVA237 in Japan therefore represents an important milestone for them ahead of an anticipated approval and launch of NVA237 in Europe over the course of the next 12 months.
In September, NVA237 was also filed for an approval in the European Union as a once-daily treatment for COPD under the brand name Seebri Breezhaler.
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