Merck will appeal EMA’s Movectro decision
pharmafile | October 12, 2010 | News story | Sales and Marketing | CHMP, EMA, Merck KGaA, Merck Serono, Movectro
Merck KGaA is poised to appeal the EMA’s decision on its MS treatment Movectro after the regulator rejected the drug last month.
The German pharma firm said it would for a re-examination of the CHMP’s negative recommendation of the drug as a treatment for relapsing remitting multiple sclerosis.
Head of the company’s Merck Serono division Elmar Schnee said: “We are committed to the potential of Movectro tablets to meet an unmet medical need and to make this treatment option available to patients who could benefit from it.
“We will continue working closely with the CHMP to address the committee’s concerns and pursue a way forward,” Schnee added.
The reasons for the negative EMA decision on Movectro have not yet been released, but regulatory advisors at the CHMP are thought to have been concerned about four cancer cases seen in trials, as well as the drug’s effect of suppressing the immune system.
Novartis stole a march over Merck in September when its rival MS drug Gilenya was approved by the FDA, making it the first oral MS treatment to reach the US market.
Merck is still waiting for a decision by the FDA on its Movectro and this is expected by the fourth quarter.
Ben Adams
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