
Merck Serono halts Movectro European licence application
pharmafile | February 18, 2011 | News story | Medical Communications, Sales and Marketing | Cladribine, MS, Merck KGaA, Merck Serono, Movectro, fingolimod, gilenya, multiple sclerosis
Merck Serono has withdrawn its European licence application for multiple sclerosis drug Movectro.
Movectro (cladribine) is a new oral treatment for MS, but has received two negative opinions from the CHMP in September and then again last month.
A decision by the European Commission was expected in April, but Merck Serono has decided to withdraw the application of its own accord.
Spokesman Steffen Muller told Pharmafocus it took the decision because the two negative CHMP opinions “pushed the balance of a positive opinion” away from them.
He said that the company would look to resubmit after it knows the outcomes of three late-stage trials – ORACLE, ONWARD and the CLARITY extension study, the results of which are expected by early 2012.
Merck Serono has also had difficult time with Movectro in the US, where the FDA sent it a ‘refuse to file’ letter in late 2009.
The regulator is still considering the drug’s future and Muller said the decision would not be affected by the company’s actions in Europe. A decision by the US regulator is expected at the end of this month, he added.
Merck Serono’s decision is good news for its rival Novartis, whose own oral MS drug Gilenya (fingolimod) gained US approval last year.
Gilenya is also poised to be approved in Europe, having received a positive opinion from the CHMP last month meaning it could be on the European market by April.
Ben Adams
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