According to the CHMP, the benefits from using the drug to treat MS did not justify its risks.
Recently, Merck’s MS pill got Austrailian and Russian approval and are under regulatory review in other countries, including the US where the application has been granted Priority Review by the FDA.
The company has filed the registration application on the basis of the results from Clarity trial, the placebo-controlled Phase III clinical trial in relapsing-remitting MS.
Merck Serono president Elmar Schnee said that they are disappointed by the CHMP opinion, but remain fully committed to the potential of Cladribine tablets to meet an unmet medical need as an oral, short-course, diseasemodifying drug for multiple sclerosis.
“With the considerable support of the multiple sclerosis community and backed by the recent approvals in Australia and Russia, we will continue to work with the CHMP to address the committee’s concerns and pursue a way forward to make Cladribine tablets available to patients from the European Union,” Schnee said.