Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that it has notified the European Medicines Agency (EMA) of its intention to request a re-examination of the opinion issued by the Committee for Medicinal Products for Human Use (CHMP) in September regarding Cladribine Tablets as a treatment for relapsing-remitting multiple sclerosis (MS).
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 approximately 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.
In accordance with European regulations, applicants may appeal a CHMP opinion provided they notify the EMA in writing of their intention to appeal within 15 days of receipt of the opinion. The applicant must provide to the agency with detailed grounds for a re-examination of the opinion within 60 days after receipt of the opinion.
Merck 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. Merck Serono initiated global filings for Cladribine Tablets in mid-2009 and, to date has submitted regulatory applications for Cladribine Tablets covering about 40 countries. Cladribine Tablets was approved in Russia in July 2010 and in Australia in September 2010.
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.