CHMP of The EMA Has Recommended Astellas Pharma Europe's Betmigatm

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended Astellas Pharma Europe's Betmigatm (mirabegron) for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence in adult patients with overactive bladder (OAB) syndrome.

The recommendation requires to be ratified by decision of the European Commission which is expected within the next 74-90 days and if approved Betmigatm will be a new OAB treatment and an alternative option to antimuscarinics.

Mirabegron, a once daily oral ß3-adrenoceptor agonist stimulates the ß3 receptors in the detrusor muscle of the bladder2 providing relaxation to the bladder muscle during the storage phase of the micturition cycle.

CHMP has given authorisation recommendation after the review of clinical trial evidence from various studies, which included patients administered with mirabegron.