Cladribine Tablets Receives Positive CHMP Opinion for Treatment of Relapsing Forms of Multiple Sclerosis

– Merck, a leading science and technology company, today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for approval of Cladribine Tablets (proposed tradename MAVENCLAD[
TM
]) for the treatment of relapsing forms of multiple sclerosis (RMS) in patients with high disease activity.

(Logo: http://photos.prnewswire.com/prnh/20170421/492737LOGO ) (Photo: http://mma.prnewswire.com/media/527002/Belen_Garijo.jpg ) (Photo: http://mma.prnewswire.com/media/527003/Luciano_Rosetti.jpg ) (Photo: http://mma.prnewswire.com/media/527004/Professor_Gavin_Giovannoni.jpg ) (Photo: http://mma.prnewswire.com/media/527005/Cladribine_Tablets_Backgrounder.jpg )

“The positive opinion from the CHMP is an extraordinary development for Merck, affirming our belief in Cladribine Tablets as a potential important treatment option for patients living with multiple sclerosis,” said Bele’n Garijo, CEO Healthcare and Member of the Executive Board of Merck. “We now eagerly await the European Commission decision, and the opportunity to make a difference in the MS treatment paradigm. Our sincerest thanks to the entire MS community for their unwavering support throughout the Cladribine Tablets journey.”

“We strongly believe in the therapeutic value of Cladribine Tablets and the significant impact this investigational therapy may have on the future of MS care,” said Luciano Rossetti, Global Head of R&D for the Biopharma business of Merck. “There are still significant unmet needs for patients with MS, particularly those with high disease activity. We look forward to our continued partnership with the EMA, which has been an invaluable scientific advisor in helping us advance the development of Cladribine Tablets.”

The CHMP positive opinion is based on more than 10,000 patient years of data with over 2,700 patients included in the clinical trial program, and more than 10 years of observation in some patients. The clinical development program included data from three Phase III trials, CLARITY, CLARITY EXTENSION and ORACLE MS, the Phase II ONWARD study and long-term follow-up data from the 8-year prospective registry, PREMIERE. The efficacy and safety results of these studies allowed a full characterization of the benefit-to-risk profile of Cladribine Tablets.

In patients with high disease activity, post hoc analyses of the two-year Phase III CLARITY trial demonstrated that Cladribine Tablets reduced the annualised relapse rate by 67% and the risk of 6-month confirmed EDSS progression by 82% versus placebo. As demonstrated in the Phase III CLARITY EXTENSION study no further Cladribine treatment was required in Years 3 and 4. The comprehensive dataset has informed the posology and monitoring requirements. The most important side effects are lymphopenia, which can be severe and long-lasting, and infections, including herpes zoster.

The CHMP’s recommendation will be referred to the European Commission which is expected to make a final decision on the marketing authorisation application for Cladribine Tablets within 67 days from the CHMP opinion.

MAVENCLAD™ is the proprietary name submitted to EMA for the investigational medicine Cladribine Tablets.

About MAVENCLAD[TM]

MAVENCLAD™ (cladribine tablets) is an investigational short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of MS. MAVENCLAD is currently under clinical investigation and not yet approved for the treatment for any use in the United States, Canada and Europe. In July 2016, the European Medicines Agency (EMA) accepted for review the Marketing Authorisation Application (MAA) of MAVENCLAD™ for the treatment of relapsing remitting multiple sclerosis.

The clinical development program for MAVENCLAD includes:

About Multiple Sclerosis (MS)

Multiple sclerosis (MS) is an autoimmune, chronic and inflammatory condition that affects the central nervous system (CNS) and is the most common, non-traumatic, disabling neurological disease in young adults. Relapsing remitting MS (RRMS) is the most common form of MS, and around 85% of people with MS are diagnosed with this type.[1] The exact cause of MS is unknown but it is thought that the body’s immune system attacks myelin, disrupting the information flow along the nerves. There is currently no cure for MS, but treatments are available to help slow the course of the disease.

All Merck Press Releases are distributed by e-mail at the same time they become available on the Merck Website. Please go to http://www.merckgroup.com/subscribe to register online, change your selection or discontinue this service.

About Merck

Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life – from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of € 15.0 billion in 66 countries.

Founded in 1668, Merck is the world’s oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.

(Immediapress – Adnkronos
Immediapress e’ un servizio di diffusione di comunicati stampa in testo originale redatto direttamente dall’ente che lo emette. Padovanews non e’ responsabile per i contenuti dei comunicati trasmessi.)