Merck Serono pulls European application for oral MS drug Movectro; Sun withdraws topotecan

The European Medicines Agency says it has been formally notified by Merck Serono Europe, a division of Germany’s Merck KGaA (MRK: DE), of its decision to withdraw its application for a centralized marketing authorization for Movectro (cladribine).

Movectro was intended to be used for the oral treatment of relapsing-remitting multiple sclerosis. The marketing application authorization for Movectro was initially submitted to the Agency on July 6, 2009. On September 23, last year, the EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of the marketing authorization for Movectro. On the request of the company, the CHMP re-examined its initial opinion and confirmed the refusal on January 20 this year (The Pharma Letters passim). At the time of withdrawal, the final CHMP recommendation for the refusal of the marketing authorization was pending European Commission decision.

In its official letter, the company stated that its decision to withdraw the application was based on the CHMP's adopted opinion that the data available to date did not allow the Committee to adopt a positive opinion recommending the authorization of Movectro.