DARMSTADT, Germany — The Food and Drug Administration declined to approve a Merck KGaA drug designed to treat relapsing-remitting multiple sclerosis.
The drug maker said it received a complete response letter from the FDA on Wednesday for cladribine tablets, Merck’s proprietary investigational oral formulation of cladribine. The regulatory agency noted in the CRL that Merck did provide substantial evidence of cladribine tablets’ effectiveness in its CLARITY1 study, but requested Merck provide an improved understanding of safety risks and the overall benefit-risk profile either through additional analyses or by additional studies.
“Our commitment to transform the way people living with MS approach their therapy options remains steadfast,” said Fereydoun Firouz, president and CEO of Merck’s U.S. subsidiary, EMD Serono. “We look forward to working with the FDA to address the safety issues in its letter and will continue to move toward identifying a potential path that provides patients and physicians the opportunity to have access to cladribine tablets in the treatment of MS.”
Cladribine tablets are approved and available under the trade name Movectro in Australia and Russia as a treatment of relapsing-remitting MS. Merck noted the tablets also are under regulatory review in other countries.