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MAVENCLAD® (Cladribine Tablets) Approved As The First Short-Course Oral Treatment for Relapsing Remitting Multiple Sclerosis in Switzerland

Nachrichtenagentur: news aktuell
25.03.2019, 14:15  |  480   |   |   
Darmstadt, Germany (ots/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

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"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 trial2,[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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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 for more information.

The clinical development program for cladribine tablets includes:

- The CLARITY (Cladribine Tablets Treating MS Orally) study: a

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