FDA accepts ciclesonide NDA from Nycomed partner Sunovion

Swiss drugmaker Nycomed, the subject of a $13.7 billion takeover bid from Japan’s Takeda (TYO:4502; The Pharma Letter May 19), says its US licensing partner Sunovion Pharmaceuticals has had its New Drug Application for ciclesonide nasal aerosol in a hydrofluoroalkane (HFA) formulation, accepted by the US Food and Drug Administration.

The drug, which was originated by the Swiss firm’s Altana subsidiary, is already marketed by Nycomed and its partners under various trade names including Alvesco and Omnaris.

The proposed dosing for ciclesonide HFA nasal aerosol is 74mcg once-daily (37mcg per spray; one-spray per nostril) and the proposed indication is for the treatment of symptoms of seasonal allergic rhinitis (SAR) and perennial allergic rhinitis (PAR), in adults and adolescents age 12 and older. Nycomed granted Sunovion exclusive development, marketing and commercialization rights for ciclesonide in the USA. The delivery system for ciclesonide HFA nasal aerosol is a pressurized metered-dose, nasal aerosol formulation designed to dispense a small volume (50mcL) of the fine, dry mist of ciclesonide to a patient's nose.