Researchers from Merck (Darmstadt, Germany) have stated that a resubmission of the New Drug Application for cladribine tablets (CTs) has been accepted for filing by the US FDA. If approved, CTs could be a potential new treatment for patients with relapsing forms of multiple sclerosis (MS).
MS is thought to affect 2.3 million people worldwide, including a large number of young adults. It is currently necessary for most MS treatments to include consistent dosing of medication. However, treatment with CTs would involve only occasional oral treatment. This could lower the burden of treatment, and could perhaps improve the quality of life for MS patients.
CTs are understood to work by the selective targeting of lymphocytes, which could be an important part of the pathological process of MS.
CTs have already been approved as an MS treatment in numerous countries across the globe, under the trade name, Mavenclad®. However, they have not yet been approved for use in the USA, following the FDA’s request for an improved understanding of safety, risks and the overall benefit profile of the tablets in 2011.
The fact that the FDA has accepted this submission for filing demonstrates that these issues may have been significantly improved since the last submission. An extensive clinical development program has been carried out, which has included nearly 12,000 patient years of data and as much as 10 years of follow-up information in some of the patients studied.
Due to their acceptance of the submission for filing, the FDA will now carry out a substantive review of the findings.
“We are delighted the FDA has accepted CTs for filing. Our goal is to offer CTs to patients and physicians in the US as a new treatment paradigm for relapsing MS, and we look forward to working closely with the FDA throughout the review process,” said Belén Garijo, Member of the Executive Board and CEO Healthcare of Merck.
If CTs are approved by the FDA, they could potentially be utilized as a new treatment for MS, and the lower treatment burden could be preferable for many patients.
“Based on additional clinical research in recent years, we know more about the treatment course, safety, and impact of CTs across several key measures of MS, and hope it will be made available to the US MS community,” concluded Thomas Leist, Director at Comprehensive Multiple Sclerosis Center at Jefferson University Hospitals (PA, USA).
Source: Merck. FDA accepts file for cladribine tablets as potential treatment for relapsing forms of multiple sclerosis. Press release: www.mrknewsroom.com/news-releases/all/all/all
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