Astellas to file for US/EU appro of OAB drug mirabegron on good Ph III results

Japanese drug major Astellas Pharma.(TSE: 4503) today announced the results of two pivotal Phase III clinical trials for mirabegron, the first of a new class of compounds under development for the treatment of overactive bladder (OAB), show mirabegron significantly improves key OAB symptoms - urinary incontinence and frequency of micturition.

Backed by the positive data, presented for the first time this week at the 26th annual congress of the European Association of Urology, in Vienna, Austria, the company said it intends to file for regulatory approval of the drug in the USA and Europe between July and September this year. Astellas submitted a market authorization application for mirabegron in Japan in June 2010.

Although more than 50% of people with overactive bladder (OAB) in the world's major pharmaceutical markets are undiagnosed, the sizeable prevalent population fuels significant sales for the indication. As a result, the OAB drug market will increase from around $3 billion in 2009 to nearly $4 billion in 2019 in the USA, France, Germany, Italy, Spain, the UK and Japan, according to advisory firm Decision Resources (The Pharma Letter October 15, 2010).