Merck KGaA's oral MS therapy gains US priority review

Merck’s cladribine has been granted a priority review status by the FDA in a move that could see it come to the US market by early 2011.

The news comes in the same month that cladribine tablets for relapsing and remitting multiple sclerosis (RRMS) were approved in Russia to become the first drug of its class to reach the market.

Merck was originally given a ‘refuse to file’ letter by the US regulator in November last year, so the accelerated review will come as a boost to the pharma branch of the German company.

“This is a critical milestone on the path to potential approval for short course therapy with cladribine tablets, moving us one step closer to meeting an unmet need as an oral, disease-modifying drug available for relapsing MS,” said Fereydoun Firouz, president and chief executive of EMD Serono, the US affiliate of Merck.

“Our commitment to people living with MS is to transform the way they approach their therapy options, and priority review for short-course therapy with cladribine tablets means we are moving closer to delivering on this promise. We look forward to working with the FDA throughout the regulatory process.”

Despite its priority review and approval in Russia, Merck KGaA lags slightly behind rival company Novartis, which is developing its own oral MS therapy in the form of Gilenia. Both drugs are in competition to replace the interferon alpha and beta-based injectables currently used to treat MS.

Gilenia was given priority review status by the FDA in February, meaning a decision is expected from the regulator in September.

Ben Adams