Merck, a leading science and technology company announced that the EMA to request the company for marketing approval for its investigational Cladribine Tablets for the treatment of relapsing multiple sclerosis (MS) to adopted examination.
“Our marketing authorization application for Cladribine Tablets underpins our ongoing commitment to a successful treatment of multiple sclerosis with their severe disabilities for those affected,” said Luciano Rossetti, head of global research and development in the biopharmaceutical business of Merck. “Although there are some therapies for relapsing-remitting MS, there is still a large unmet need, especially in terms of effectiveness, dosing schedule, durability and safety. We are convinced that in case of approval with Cladribine Tablets stands a unique dosing regimen and an important treatment option for patients with relapsing forms of MS available. ”
The NDA includes data from three Phase III studies: CLARITY, CLARITY EXTENSION and ORACLE MS and the phase II study ONWARD. In these studies with Cladribine Tablets in patients with relapsing-remitting MS compared to placebo, a significant reduction in relapse rate, the risk of disability progression and the development of new, made in MRI visible MS lesions. 1,2,3,4,5 Together with the interim data from the long-term follow from the prospective registry PREMIERE includes the new application for admission and follow-up data, which include more than 10,000 patient-years of exposure, with some patients were followed for more than eight years. 6
. 1 A Placebo-Controlled Trial of Oral Cladribine for Relapsing Multiple Sclerosis. New England Journal of Medicine .Http://www.nejm.org/doi/full/10.1056/NEJMoa0902533 , called on 5 May 2016th
2. Safety and Efficacy of Oral Cladribine in Patients with Relapsing-Remitting Multiple Sclerosis: Results from the 96 Week Phase IIIb Extension Trial to the CLARITY Study (P07.119). called on 5 May 2016th
3. Effect of Oral Cladribine on Time to Conversion to Clinically Definite Multiple Sclerosis in Patients with a First Demyelinating Event (ORACLE MS): A Phase 3 Randomised Trial. Lancet Neurology.Http://www.ncbi.nlm.nih.gov/pubmed/24502830 , called on 5 May 2016th
4. A Phase 2 Study of Cladribine add-on to interferon-beta (IFN-beta) Therapy in Multiple Sclerosis (MS) Subjects With Active Disease (ONWARD). Clinical called on 5 May 2016th
5. Efficacy of Cladribine Tablets as an add-on to IFN-beta Therapy in Patients with Active Relapsing MS: Final Results from the Phase II ONWARD Study. American Academy of Neurology 2016 meeting abstracts.Http://www.abstractsonline.com/pp8/#!/4046/presentation/9728 , called on 10 May 2016.
6. Current and Emerging Therapies for the Treatment of Multiple Sclerosis. Focus on Cladribine Journal of Central Nervous System Disease . Http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3619698/called on June 14, 2016
In the preparation Cladribine Tablets is an oral low-molecular prodrug that selectively targets and periodically on lymphocytes, which are to be heavily involved in the pathological process of MS. Cladribine Tablets are currently in clinical trials and are not yet in the US, Canada and Europe approved for the treatment. Multiple Sclerosis Multiple sclerosis (MS) is a chronic inflammatory disease of the central nervous system and the most common, non-traumatic, disabling neurological disease in young adults. It is estimated that approximately 2.3 million people have MS worldwide. The symptoms can vary, the mainly blurred vision, numbness or tingling in the limbs and loss of strength and coordination problems. Are the most common, the relapsing forms of MS.