cladribineTreatment for Multiple Sclerosis
NDA for Cladribine Tablets to be Resubmitted
Merck Resubmits U.S. Application for Cladribine Tablets as a Potential MS Therapy
Darmstadt, Germany, June 8, 2010 - Merck KGaA announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Cladribine Tablets as a therapy for reducing relapses in people with relapsing forms of multiple sclerosis (MS). The company received a refuse to file letter from the FDA for the Cladribine Tablets NDA in November 2009.
Regulatory filings for Cladribine Tablets are currently under review in a number of other locations including the European Union.
About Cladribine Tablets
Merck Serono's proprietary 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.
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 its two-year extension 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.
About multiple sclerosis
Multiple sclerosis (MS) is a chronic, inflammatory condition of the central nervous system and is the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that more than two million people have MS worldwide. While symptoms can vary, the most common symptoms of MS include blurred vision, numbness or tingling in the limbs and problems with strength and coordination. The relapsing forms of MS are the most common.
Contact Phyllis Carter +49 6151 72-7144
Posted: June 2010
- Merck: Regulatory Update on Cladribine Tablets - June 22, 2011
- Merck Receives Complete Response Letter From FDA on Cladribine Tablets New Drug Application - March 2, 2011
- Merck KGaA Announces Extension of FDA Priority Review Period for Cladribine Tablets for the Treatment of Relapsing Forms of MS - November 29, 2010
- FDA Grants Priority Review to Cladribine Tablets for the Treatment of Relapsing Forms of Multiple Sclerosis - July 28, 2010
- Merck KGaA Receives Refuse to File Letter from FDA on Cladribine Tablets New Drug Application - November 30, 2009
- Merck Submits Application for Cladribine Tablets as a Potential Oral Short-Course Multiple Sclerosis Therapy in the United States - October 2, 2009