Good news from CHMP for Astellas, Savient, Bayer and Abbott, but not for Lundbeck and Merz

Among a batch of news for drugmakers released last Friday, the European Medicines Agency's Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Japanese drug major Astellas (TYO: 4503) Betmiga (mirabegron) for the symptomatic treatment of urgency, increased micturition frequency and/or urgency incontinence as may occur in adult patients with overactive bladder (OAB) syndrome.

The opinion now needs ratification by the European Commission, which is expected within the next 74-90 days. If approved, mirabegron will be the first in a new class of OAB treatment, offering healthcare professionals an alternative option to antimuscarinics (currently the only licensed oral treatment option) when treating patients with OAB.

Mirabegron is a once daily oral beta3-adrenoceptor agonist with a distinct mechanism of action compared to antimuscarinics, the current treatment standard. Antimuscarinics work by binding to muscarinic receptors in the bladder and inhibiting involuntary bladder contractions. Mirabegron works by stimulating the beta3 receptors in the detrusor muscle of the bladder causing relaxation of the bladder muscle during the storage phase of the micturition cycle. This improves the storage capacity of the bladder without inhibiting bladder voiding