BioMarin Could Launch Brineura Concurrently In US And Europe

Apr 24 2017

• By John Davis

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The EU’s top advisory panel, the CHMP, has given a green light to BioMarin’s late-infantile Batten disease therapy, Brineura, one of the first therapies for the ultra-rare and fatal disease, a decision that comes just days before a US FDA decision is expected on the replacement enzyme therapy.

A positive EU CHMP opinion for the use of BioMarin Pharmaceutical Inc.’s Brineura (cerliponase alfa) in CLN2 disease, the late-infantile form of Batten disease, has come just days before a US PDUFA date of April, 27, 2017 for the product, suggesting US approval for the drug could be closely followed by European approval and near-concurrent launch of the product on two major markets.

BioMarin says it is ready to commercialize the orphan drug; “We will be able to commercialize Brineura within two weeks...

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