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. 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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