EMD Serono Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United
Posted Nov 17 2009 10:20pm
Source: EMD Serono, Inc. - On Wednesday September 30, 2009
ROCKLAND, Mass., Sept. 30 /PRNewswire/ -- EMD Serono, Inc. an affiliate of Merck KGaA, Darmstadt, Germany, announced today the submission of a New Drug Application (NDA) to the US Food and Drug Administration (FDA) for Cladribine Tablets, EMD Serono's proprietary investigational oral formulation of cladribine, as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS). Cladribine Tablets has the potential to be the first orally administered disease-modifying therapy available for people living with relapsing MS, as all disease-modifying therapies currently approved for the treatment of MS are parenteral therapies.
"As a leader in the area of neurodegenerative diseases, we continue to focus on making a positive difference in the lives of people living with MS, and their families," said Fereydoun Firouz, President and CEO of EMD Serono, Inc. "If approved, short-course therapy with Cladribine Tablets could transform the way people approach their treatment options, and meet an unmet need as an oral, disease modifying drug available for MS. We look forward to working with the FDA during the course of the regulatory process."