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news.The US Food and Drug Administration (FDA) has issued complete response letter (CRL) to Merck KGaA affiliate EMD Serono's new drug application (NDA) for Cladribine tablets for the treatment of relapsing-remitting multiple sclerosis (MS).
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FDA said the CRL was issued based on the results from Clarity study.
However, the FDA has requested EMD Serono to provide an improved understanding of safety risks and the overall benefit-risk profile either through additional analyses or by additional studies.
EMD Serono president and CEO Fereydoun Firouz said they look forward to working with the FDA to address the safety issues in its letter and will continue to move toward identifying a path that provides patients and physicians the opportunity to have access to Cladribine tablets in the treatment of MS.