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

22 October 2012

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.

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