Updated on 18 January 2013
Good news for overactive bladder patients - Betmigatm (mirabegron) has been approved by the European Commission (EC)
Singapore: Mirabegron has been approved by the European Commission (EC) for the treatment of overactive bladder (OAB) symptoms in adults. The drug is the first new class of treatment that has been developed for OAB in the past 30 years.
Mirabegron will provide doctors with an alternative medication to antimuscarinic agents, which presently are the only class of approved oral treatment available. Mirabegron has a completely different mechanism of action to antimuscarinics. It improves the storage capacity of the bladder without inhibiting bladder voiding, thereby prolonging the time between trips to the toilet for the patient.
Dry mouth is one-of-the-most common side effects of antimuscarinics and is often the reason for discontinuation of treatment in patients. Comparatative studies have shown that mirabegron has a low incidence of treatment-associated side effects, including dry mouth.
The European Commission granted approval of mirabegron following the recommendation by the Committee for the Medicinal Products for Human Use (CHMP) in October 2012. They reviewed extensive clinical trial evidence from seven phase II/III studies in which over 5,000 patients received mirabegron, including three phase III double-blind, randomized controlled trials conducted in the US and Europe-Australia.
During the trials, mirabegron demonstrated superior efficacy as compared to placebo in the treatment of symptoms of OAB, with patients needing to visit a toilet significantly less frequently and experiencing fewer incontinence episodes. In terms of quality of life, treatment of the symptoms of OAB with mirabegron once daily has also demonstrated statistically significant improvements over placebo on quality of life measures of treatment satisfaction and symptom bother.