Country for PR: United Kingdom
Contributor: PR Newswire Europe
Thursday, December 07 2017 - 20:40
AsiaNet
Merck Receives Approval (Updated Registration) for Mavenclad (Cladribine Tablets) in Australia
DARMSTADT, Germany, Dec 7, 2017/PRNewswire-AsiaNet/ --

Not intended for U.K./U.S. based media

    - First treatment in relapsing-remitting multiple sclerosis (RRMS) to show 
sustained clinical efficacy for up to 4 years with a maximum of 20 days of oral 
treatment over 2 years
    - Updated registration follows recent approval of Mavenclad in Europe and 
Canada 

    Merck, a leading science and technology company, today announced that the 
Therapeutic Goods Administration (TGA) has updated the registration including 
the indication, dosing and safety information of MAVENCLAD(R) (cladribine 
tablets) for the treatment of relapsing-remitting multiple sclerosis (RRMS) in 
Australia. As a result, MAVENCLAD(R) is now approved for the treatment of 
relapsing-remitting multiple sclerosis (RRMS) to reduce the frequency of 
clinical relapses and to delay the progression of physical disability. 
Following completion of 2 courses of treatment, no further treatment is 
required in years 3 and 4. The changes bring the Product Information[1] in line 
with the latest clinical trial evidence supporting MAVENCLAD(R). MAVENCLAD(R) 
is the first and only oral short-course treatment to provide efficacy across 
key measures of disease activity in patients with RRMS, including disability 
progression, annualized relapse rate and magnetic resonance imaging (MRI) 
activity.

     (Logo: https://mma.prnewswire.com/media/472778/Merck_Logo.jpg) 

    "Multiple sclerosis is a debilitating disease where new treatments are 
needed," said Professor Bill Carroll, Clinical Professor of Neurology at the 
University of Western Australia and the Perron Institute, and a consultant 
neurologist at the Sir Charles Gairdner Hospital as well as President-elect of 
the World Federation of Neurology. "Mavenclad will be a welcomed treatment 
option for patients with the relapsing-remitting form of MS. As an oral therapy 
taken in two short courses over a 2-year period, Mavenclad will be convenient 
for all eligible patients in Australia, including those who may not live close 
to their treating healthcare professional."

    "We are pleased the Therapeutic Goods Administration has updated the 
Product Information for Mavenclad in Australia to reflect additional clinical 
data," said Simon Sturge, Chief Operating Officer at the biopharma business of 
Merck. "Our next step is to work closely with the Australian government to 
bring this treatment advance to patients as quickly as possible."

    MAVENCLAD(R) has been subject to a comprehensive clinical development 
program in multiple sclerosis (MS), that includes more than 10,000 patient 
years of data with over 2,700 patients included in the clinical trial 
programs,[2] and up to 10 years of observation in some patients.

    MAVENCLAD(R) is a selective immune reconstitution therapy[3],[4] which 
simplifies treatment administration, by giving patients just 2 short annual 
courses of tablets with a maximum of 20 days of treatment over 2 years 
providing a lasting treatment benefit of at least 4 years. MAVENCLAD(R) works 
by selectively targeting B & T lymphocytes followed by a distinct pattern of 
lymphocyte reconstitution, without continuous suppression of the immune 
system.[5]

    This registration update for MAVENCLAD(R) in Australia follows the recent 
approval of MAVENCLAD(R) in Europe and in Canada. MS affects more than 23,000 
Australians with most people diagnosed between the ages of 20-40.[6] Merck 
plans additional filings for regulatory approval in other countries, including 
the United States.

    MAVENCLAD(R) Minimum Product Information: Indications: MAVENCLAD is 
indicated for the treatment of relapsing-remitting multiple sclerosis (RRMS) to 
reduce the frequency of clinical relapses and to delay the progression of 
physical disability. Following completion of the 2 treatment courses, no 
further cladribine treatment is required in years 3 and 4. Re-initiation of 
therapy after year 4 has not been studied. Contraindications: Patients with 
hypersensitivity to cladribine or to any of the tablet excipients, infected 
with the human immunodeficiency virus (HIV), active chronic infections 
(tuberculosis, hepatitis), immunocompromised patients, including patients 
receiving immunosuppressive or myelosuppressive therapy, moderate or severe 
renal impairment (creatinine clearance < 60 mL/min), during pregnancy and 
breastfeeding. Precautions: Haematological monitoring is required prior to and 
during therapy. Lymphopenia; Infections; Malignancies; Switching to and from 
MAVENCLAD treatment; Renal impairment; Hepatic impairment; Fructose 
intolerance; Effects on fertility (incl. male patients), Use in pregnancy 
(Category D) and lactation; Use in Paediatric or Elderly; Carcinogenicity, 
Genotoxicity. Interactions: 3 hours interval required for administration of 
other oral medicines. Concomitant treatment with immunosuppressive or 
myelosuppressive agents is contraindicated; must not be initiated within 4 to 6 
weeks after vaccination with live/live-attenuated vaccines. Recommendations to 
avoid co-administration with potent ENT1, CNT3 and ABCG2 transporter 
inhibitors. Adverse reactions: Very Common:Lymphopenia (may be severe, Grade 3 
or 4). Common: Rash, alopecia, oral herpes, dermatomal herpes zoster, decrease 
in neutrophil count. Dosage and administration:Haematological and infections 
screening criteria for starting and continuing therapy have to be met before 
initiating MAVENCLAD therapy or administering any subsequent treatment course. 
The recommended cumulative dose of MAVENCLAD is 3.5 mg/kg body weight over 2 
years, administered as 1 treatment course of 1.75 mg/kg per year. Each 
treatment course consists of 2 treatment weeks, one at the beginning of the 
first month and one at the beginning of the second month of the respective 
year. Each treatment week consists of 4 or 5 days on which a patient receives 
10 mg or 20 mg (one or two tablets) as a single daily dose, depending on body 
weight. Patients should receive no more than 2 treatment courses over two 
consecutive years. The recommended dose should not be exceeded. Following 
completion of the 2 treatment courses, no further cladribine treatment is 
required in year 3 and year 4. Re-initiation of therapy after year 4 has not 
been studied.

    Based on approved PI dated 5 December 2017

    About MAVENCLAD(R)

    MAVENCLAD(R) (cladribine tablets) is approved in the European Union for the 
treatment of highly active relapsing multiple sclerosis (RMS). MAVENCLAD(R) is 
approved in Canada and Australia for the treatment of relapsing-remitting 
multiple sclerosis (RRMS). MAVENCLAD(R) is a short-course oral therapy that 
selectively 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 cladribine tablets 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(R) is 
currently under clinical investigation and not yet approved for the treatment 
for any use in the United States.

    The clinical development program for MAVENCLAD(R) 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(R) as a monotherapy in patients with RRMS.
    - The CLARITY extension study: a two-year Phase III placebo-controlled 
study following on from the CLARITY study, designed to evaluate the safety and 
efficacy of MAVENCLAD(R) 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(R) 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(R)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(R) 

    The clinical development program of Cladribine in MS comprises 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.

    About Multiple Sclerosis

    Multiple sclerosis (MS) is a chronic, inflammatory condition of the central 
nervous system and is the most common, non-traumatic, disabling neurological 
disease in young adults. It is estimated that approximately 2.3 million people 
have MS worldwide. While symptoms can vary, the most common symptoms of MS 
include blurred vision, numbness or tingling in the limbs and problems with 
strength and coordination. The relapsing forms of MS are the most common.

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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 EUR 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.

    [1]. Approved MAVENCLAD(R) Product Information (2017)

    [2]. Merck data on file

    [3]. Giovannoni G. Personalized medicine in multiple sclerosis. 2017 
Neurodegenerative Disease Management; 7 (6s) 13-17

    [4]. Giovannoni G. Cladribine to Treat Relapsing Forms of Multiple 
Sclerosis. Neurotherapeutics. November 2017; DOI 10.1007/s13311-017-0573-4

    [5]. MAVENCLAD(TM) Product Monograph. November 2017

    [6]. https://www.msaustralia.org.au/what-ms

    Source: Merck