FDA extends review period of Cladribine Tablets for MS therapy

Nov 26 2010

EMD Serono, an affiliate of Merck KGaA, Darmstadt, Germany, announced today that the U.S. Food and Drug Administration (FDA) has extended its review period for Cladribine Tablets as a therapy for relapsing forms of multiple sclerosis (MS) by three months to February 28, 2011.

The FDA granted Priority Review status for Cladribine Tablets in July of 2010, reducing the standard 10-month review period to six months, which was set to end on November 28, 2010. The FDA extended the review period to provide additional time for a full review of additional information provided under the new drug application (NDA).

"EMD Serono continues to work closely with the FDA during the review process of the Cladribine Tablets new drug application," said Bernhard Kirschbaum, Head of Global Research and Development, Merck Serono, a division of Merck KGaA, Darmstadt, Germany. "We will continue working towards our goal of providing an oral disease-modifying drug for the treatment of relapsing multiple sclerosis."