DARMSTADT, Germany, March 25, 2019 /PRNewswire/ --
-- MAVENCLAD() is now approved in 52 countries worldwide -- Approval brings forward new treatment option with a novel mechanism for highly active relapsing multiple sclerosis in Switzerland -- Approval based on extensive clinical development program capturing more than 10,000 patient years of safety data and up to 10 years of follow-up in some patients -- MAVENCLAD() provides the possibility of up to four years of disease control with a maximum of 20 days of oral treatment administered over two years
Merck, a leading science and technology company, today announced that MAVENCLAD() (cladribine tablets) has been approved for the treatment of highly active relapsing remitting multiple sclerosis* (RRMS)([1]) in Switzerland. MAVENCLAD() is the first treatment for RRMS that provides the possibility of up to four years of disease control with a maximum of 20 days of oral treatment administered over two years.
"The Swissmedic approval of MAVENCLAD is great news for patients in Switzerland with highly active relapsing remitting MS," said Luciano Rossetti, Head of Global Research & Development for the Biopharma business of Merck. "These patients have had limited treatment options and MAVENCLAD, now approved in 52 countries worldwide, represents an important new therapy with a novel mechanism as the first short-course oral treatment for relapsing remitting MS in Switzerland."
MAVENCLAD() has demonstrated durable clinical efficacy for up to four years across key measures of disease activity, including disability progression, annualized relapse rate and magnetic resonance imaging (MRI) activity. The approval of MAVENCLAD() is based on more than 10,000 patient years of data with over 2,700 patients included in the clinical trial program, and up to 10 years of observation in some patients. The clinical development program included data from three placebo-controlled Phase III trials, CLARITY (pivotal efficacy study)([2],[3]) CLARITY EXTENSION([4]) and ORACLE MS,([5]) the Phase II ONWARD study;([6]) and long-term follow-up data from the 8-year prospective registry, PREMIERE.([7]) The efficacy and safety results of these studies allowed for a full characterization of the benefit-to-risk profile of MAVENCLAD().
"To receive a reliably effective therapy remains the most important consideration for patients," said Professor Ludwig Kappos, Chair, Neurology, University Hospital Basel, Switzerland. "The medium and long-term treatment risks ought to be as low as possible. Last but not least the treatment should be very compatible with a normal daily life. The approval of MAVENCLAD for highly active relapsing remitting multiple sclerosis by Swissmedic in Switzerland is good news because it extends the range of options for this group of MS patients with an oral treatment with proven, long-lasting effect."
In patients with high disease activity, post hoc analyses of the two-year Phase III CLARITY trial(2)(,[8]) demonstrated that MAVENCLAD() reduced the annualized relapse rate by 67% and the risk of 6-month confirmed Expanded Disability Status Scale (EDSS) progression by 82% versus placebo. As demonstrated in the Phase III CLARITY EXTENSION study, no further MAVENCLAD() treatment was required in Years 3 and 4.([9]) MAVENCLAD() has a well-characterized safety profile, with up to ten years of observation in some patients and no reported cases of progressive multifocal leukoencephalopathy (PML) in MS. The most clinically relevant adverse reactions were lymphopenia and herpes zoster. Lymphocyte counts must be assessed before, and during, treatment with MAVENCLAD(). MAVENCLAD( )is contraindicated in certain groups including immunocompromised patients and pregnant women.
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About MAVENCLAD()
MAVENCLAD() is a short-course oral therapy that selectively and periodically targets lymphocytes thought to be integral to the pathological process of relapsing MS (RMS). In August 2017, the European Commission (EC) granted marketing authorization for MAVENCLAD() for the treatment of relapsing forms of multiple sclerosis (RMS) in the 28 countries of the European Union (EU) in addition to Norway, Liechtenstein and Iceland. MAVENCLAD() has since then been approved in more than 50 countries, including Canada and Australia. MAVENCLAD() is currently under clinical investigation and not yet approved for the treatment for any use in the United States.
Visit www.MAVENCLAD.com [http://www.mavenclad.com/] for more information.
The clinical development program for cladribine tablets 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 cladribine tablets as a monotherapy in patients with RRMS. -- The CLARITY extension study: a Phase III placebo-controlled study following on from the CLARITY study, which evaluated the safety and exploratory efficacy of cladribine tablets over two additional years beyond the two-year CLARITY study, according to the treatment assignment scheme for years 3 and 4. -- 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 cladribine tablets 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 cladribine tablets 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) study: a long-term observational follow-up safety registry of MS patients who participated in cladribine tablets clinical studies.
In the two-year CLARITY study, the most commonly reported adverse event (AE) in patients treated with cladribine tablets was lymphopenia (26.7% with cladribine tablets and 1.8% for placebo). The incidence of infections was 48.3% with cladribine tablets and 42.5% with placebo, with 99.1% and 99.0% respectively rated mild-to-moderate by investigators. Adverse Events reported in other clinical studies were similar.(2)
Swiss Indication and Important Safety Information
Mavenclad() (10 mg cladribine)
(CONTINUA)
