Astellas' Betmiga Oked in EU for overactive bladder

The European subsidiary of Japanese drug major Astellas Pharma (TYO: 4503) has received approval from the European Commission for its Betmiga (mirabegron) for the treatment of overactive bladder (OAB) symptoms in adults.

Mirabegron, which was cleared for marketing in the USA under the brand name Myrbetriq last year (The Pharma Letter July 2, 2012), represents the first new class of treatment in OAB for over 30 years. Currently around half of patients discontinue OAB treatment after only three months, often due to lack of efficacy or side effects, noted Astellas, so it is important that doctors will now be able to offer patients an alternative treatment that works in a different way.

OAB affects more than 400 million people worldwide. In Europe, OAB affects around 17% of men and women and increases to 30%-40% for those aged over 75 years. In a survey carried out in OAB patients, 65% felt OAB had adversely affected their daily life. Symptoms can affect family, social and work life, as well as mental and physical wellbeing, and across OAB patients, depression scores are higher, whilst quality of life scores are lower.