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Astellas Pharma, Inc. (ALPMY) recently announced the receipt of EU approval for its overactive bladder (OAB) candidate, Betmiga (mirabegron).

Betmiga gained approval from the European Commission (EC) for the treatment of overactive bladder symptoms in adults.

EU approval was largely expected as in Oct 2012, the Committee for Medicinal Products for Human Use (CHMP) had issued a positive opinion on Betmiga, recommending the granting of marketing authorization.

We note that Astellas' Betmiga is already approved in the US where it is available under the trade name, Myrbetriq. It is also approved in Japan under the trade name Betanis.

Our Take

We are encouraged by the EU approval of Betmiga. According to information provided by Astellas, OAB is estimated to affect more than 400 million people globally. According to a population-based prevalence study, 17% of men and women are affected by OAB in Europe with the prevalence increasing to 30-40% in people above 75 years of age.

Betmiga is the first once daily oral β3-adrenoceptor agonist to be approved for the treatment of OAB. Betmiga has a different mechanism of action compared to antimuscarinics, which are the current standard of treatment.

Results on Betmiga showed that it improves the storage capacity of the bladder without inhibiting bladder voiding. Thus, it has the ability to decrease the urge to urinate and leads to lower incontinence episodes. It has lower side effects as well. This should help Betmiga capture a significant share of the OAB market.

Currently approved OAB treatments include Warner Chilcott’s Enablex and Pfizer’s (PFE - Analyst Report) Toviaz.

Astellas carries a Zacks Rank #4 (Sell). Right now Valeant Pharmaceuticals (VRX - Analyst Report) looks more attractive with a Zacks Rank #1 (Strong Buy).

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