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Extension of FDA Review for Cladribine Tablets for Treatment of Relapsing Forms of Multiple Sclerosis

Author: EMD Serono, Inc.

Published: 2010-11-26 : (Rev. 2017-02-13)

Synopsis and Key Points:

EMD Serono Announces Extension of FDA Priority Review Period for Cladribine Tablets for the Treatment of Relapsing Forms of Multiple Sclerosis.

Main Digest

EMD Serono Announces Extension of FDA Priority Review Period for Cladribine Tablets for the Treatment of Relapsing Forms of Multiple Sclerosis - FDA extends Priority Review period of Cladribine Tablets by three months.

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."

Cladribine Tablets

EMD Serono's oral formulation of cladribine (Cladribine Tablets) is an investigational treatment for patients with relapsing forms of multiple sclerosis (MS). Cladribine is a small molecule that may interfere with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are thought to be involved in the pathological process of MS. Cladribine Tablets were approved in Russia in July 2010 and in Australia in September 2010 as a treatment of relapsing-remitting MS and are under regulatory review in other countries.

The clinical development program for Cladribine Tablets includes:

The CLARITY (CLAdRIbine Tablets treating MS orally) study and its extension:

A two-year Phase III placebo-controlled trial designed to evaluate the efficacy and safety of Cladribine Tablets as a monotherapy in patients with relapsing-remitting MS and the CLARITY EXTENSION two-year Phase III study designed to provide data on the long-term safety and efficacy of extended administration of Cladribine Tablets for up to four years.

The ORACLE MS (ORAl CLadribine in Early MS) study:

A two-year Phase III placebo-controlled trial designed to evaluate the efficacy and safety of Cladribine Tablets as a monotherapy in patients at risk of developing MS (patients who have experienced a first clinical event suggestive of MS). This trial was announced in September 2008.

The ONWARD (Oral Cladribine added oN to interferon beta-1a in patients With Active Relapsing Disease) study:

A Phase II placebo-controlled trial designed primarily to evaluate the safety and tolerability of adding Cladribine Tablets treatment to patients with relapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy. This trial was announced in January 2007.

The PREMIERE (PRospective observational long-term safety registry of Multiple sclerosis patients who have participated in Cladribine clinical trials) registry:

An eight-year observational safety registry of patients who have participated in Cladribine Tablets clinical trials, designed to support the evaluation of the long-term safety of Cladribine Tablets in MS.

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