FDA Approves MAVENCLAD® (Cladribine) Tablets as First and Only Short-Course Oral Treatment for Relapsing-Remitting and A

Publicado 30/03/2019 1:02:44CET

About MAVENCLAD(®) (cladribine) Tablets (10 mg)MAVENCLAD, approved by the U.S. Food and Drug Administration (FDA) on March 29(th), 2019, is the first short-course oral therapy for the treatment of relapsing forms of multiple sclerosis (RMS). MAVENCLAD is not recommended for use in patients with clinically isolated syndrome (CIS) because of the risk of malignancy. Patients should follow healthcare provider instructions including cancer screening, contraception, and blood tests. The approved dose of MAVENCLAD is 3.5 mg per kg body weight over two years, administered as one treatment course of 1.75 mg per kg per year, each consisting of two treatment weeks. The mechanism by which cladribine exerts its therapeutic effects in patients with multiple sclerosis has not been fully elucidated but is thought to involve cytotoxic effects on B and T lymphocytes through impairment of DNA synthesis, resulting in depletion of lymphocytes. MAVENCLAD causes a dose dependent reduction in lymphocyte counts followed by recovery.

Because cladribine is cytotoxic, special handling and disposal instructions should be followed.

MAVENCLAD has been approved in over 50 countries, including the European Union (EU), Canada, Australia and Switzerland, for various relapsing MS indications.

Visit www.MAVENCLAD.com [http://www.mavenclad.com/] for more information.

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.

Merck in Multiple Sclerosis Merck has a long-standing legacy in neurology and immunology, with significant R&D and commercial experience in multiple sclerosis (MS). Merck's current portfolio includes two products for the treatment of relapsing MS, with a robust pipeline focusing on discovering new therapies that have the potential to modulate key pathogenic mechanisms in MS. Merck aims to improve the lives of those living with MS, by addressing areas of unmet medical needs.

About Merck Merck, a leading science and technology company, operates across healthcare, life science and performance materials. Around 52,000 employees work to make a positive difference to millions of people's lives every day by creating more joyful and sustainable ways to live. From advancing gene editing and discovering unique ways to treat the most challenging diseases to enabling the intelligence of devices - the company is everywhere. In 2018, Merck generated sales of EUR 14.8 billion in 66 countries.

Scientific exploration and responsible entrepreneurship have been key to Merck's technological and scientific advances. This is how Merck has thrived since its founding in 1668. The founding family remains the majority owner of the publicly listed company. Merck holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the business sectors of Merck operate as EMD Serono in healthcare, MilliporeSigma in life science, and EMD Performance Materials. For more information about Merck visit www.merckgroup.com [http://www.merckgroup.com/].

Friederike Segeberg: +49-151-1454-6328
Investor Relations: +49-6151-72-3321

(Logo: https://mma.prnewswire.com/media/843875/merck_Logo.jpg [https://mma.prnewswire.com/media/843875/merck_Logo.jpg])

Web site: https://www.mavenclad.com/

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