DARMSTADT, Germany, June 23, 2017 /PRNewswire/ --
- Efficacy and safety data support positive benefit/ risk assessment from
CHMP
- Cladribine Tablets is the first and only investigational medicinal product to have shown
a sustain ed 4 years of disease control with a maximum of 20 days of oral treatment over
2 years in clinical trials
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.
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"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 Belén 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:
- The CLARITY (CLAdRIbine Tablets Treating MS OrallY) study: a two-year Phase III placebo-controlled study designed to
evaluate the efficacy and safety of MAVENCLAD as a monotherapy in patients with RRMS.
- The CLARITY extension study: a four-year Phase III placebo-controlled study following on from the CLARITY study, designed
to evaluate the safety and efficacy of MAVENCLAD over an extended administration for four years.
- The ORACLE MS (ORAl CLadribine in Early MS) study: a two-year Phase III placebo-controlled study designed to evaluate the
efficacy and safety of MAVENCLAD as a monotherapy in patients at risk of developing MS (patients who have experienced a first
clinical event suggestive of MS).
- The ONWARD (Oral Cladribine Added ON To Interferon beta-1a in Patients With Active Relapsing Disease) study: a Phase II
placebo-controlled study designed primarily to evaluate the safety and tolerability of adding MAVENCLAD treatment to patients
with relapsing forms of MS, who have experienced breakthrough disease while on established interferon-beta therapy.
- PREMIERE (Prospective Observational Long-term Safety Registry of Multiple Sclerosis Patients Who Have Participated in
Cladribine Clinical Studies) study: interim long-term follow-up data from the prospective registry, PREMIERE, to evaluate the
safety and efficacy of MAVENCLAD. The follow-up will consist of over 10,000 patient years of exposure in total, with follow-up
in some patients exceeding eight years at completion.
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.
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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.