Astellas Pharma, Inc.
) 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
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.
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
Currently approved OAB treatments include
) Enablex and
Astellas carries a Zacks Rank #4 (Sell). Right now
) looks more attractive with a Zacks Rank #1 (Strong Buy).
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