HomeNewscladribine, mavenclad, ms, multiple sclerosis, Relapsing remitting MS, RRMSMavenclad (cladribine) approved for Active RMS in UAE

Mavenclad (cladribine) approved for Active RMS in UAE

  • April 10, 2018
  • Posted by: PharmaScroll
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  • First oral short-course treatment for highly active relapsing multiple sclerosis (RMS) now approved in United Arab Emirates
  • Mavenclad has shown sustained clinical efficacy for up to 4 years with a maximum of 20 days of oral treatment over 2 years

Merck, a leading science and technology company, announced on April 9th 2018, that the United Arab Emirates Ministry of Health and Prevention, has approved the registration of MAVENCLAD® (cladribine tablets) for the treatment of adult patients with highly active relapsing multiple sclerosis (MS) as defined by clinical or imaging features. This marks the first approval for MAVENCLAD® in the Middle East & Africa region and following local regulatory processes, the product is expected to be available in the coming months. The United Arab Emirates (UAE) is the first country in the region to approve the adoption of this breakthrough therapy, which is a direct outcome of accelerated processes by the Ministry of Health and Prevention aimed at making the latest advances and best quality of healthcare services and medications available within the country.

“The accelerated processes implemented by the Ministry of Health and Prevention allow for significant advancements in care, and we applaud them for fostering an environment in which patients gain expedited access to innovations such as Mavenclad,” said Rehan Verjee, Chief Marketing and Strategy Officer at the Biopharma business of Merck.

MAVENCLAD® is the first oral short-course treatment to provide efficacy across key measures of disease activity in patients with highly active relapsing MS, 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 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 for a full characterization of the benefit-to-risk profile of MAVENCLAD®.

MAVENCLAD® is a selective immune reconstitution therapy 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 up to 4 years. MAVENCLAD® works by selectively targeting B & T lymphocytes followed by a distinct pattern of lymphocyte reconstitution, without continuous suppression of the immune system.

In patients with high disease activity, post hoc analyses of the two-year Phase III CLARITY trial 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. The comprehensive dataset has informed the posology and monitoring requirements. 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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News Source: Merck Group Website

Image Source: https://multiplesclerosisnewstoday.com/2017/08/29/relapsing-ms-treatment-mavenclad-approved-by-european-commission-merck-announces/