Astellas files for OAB drug mirabegron in USA and Europe

Japanese drug major Astellas Pharma (TYO: 4503) says it has submitted a New Drug Application and Market Authorisation Application for mirabegron (YM178) to the US Food and Drug Administration and the European Medicines Agency, seeking approval for this first in a new class of medicine for the indication of overactive bladder (OAB) associated with symptoms of urgency, urinary frequency, and urge urinary incontinence.

Mirabegron is a once daily oral selective beta3-adrenoceptor agonist discovered and developed by Astellas. The pivotal Phase III clinical trials in the USA and Europe met primary endpoints compared to placebo.

Astellas has been developing mirabegron as a global project. In Japan, the drug was granted marketing approval under the trade name of Betanis tablet in July 2011. Additionally, there is an on-going multiregional Phase III study in China, Korea, Taiwan, and India. Astellas markets the OAB drug solifenacin succinate under the trade name Vesicare) in 67 countries/areas and has contributed to improving OAB associated symptoms.