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# EMD Serono Resubmission for MS Drug
- URL: https://www.fdaweb.com/emd-serono-resubmission-for-ms-drug/
- Published: 2018-07-31T12:00:00.000Z
- Updated: 2026-09-15T00:22:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142009

FDA has accepted for review an EMD Serono NDA resubmission for cladribine tablets for treating patients with relapsing forms of multiple sclerosis (MS). The resubmission addresses a 2011 complete response letter requesting an improved understanding of safety risks and the overall benefit-risk profile. The letter said the company’s CLARITY study provided substantial evidence of cladribine’s effectiveness for the proposed indication but that the NDA could not be approved in its current form ([see earlier story](http://www.fdaweb.com/login.php?sa=v&aid=D5117536&searchWords=cladribine&cate=S&stid=%241%24v74.MW%2F.%245j3FKuwsps%2FhEmC7OJ9Te0)).  
  
Cladribine is an investigational agent that has been studied as a short-course (a maximum of 20 days of treatment over two years) oral therapy that is thought to selectively target lymphocytes, which may be integral to the pathological process of relapsing MS, the company says. It is approved under the trade name Mavenclad in 38 countries since 8/2017, including the European Union, Canada, Australia, Israel, Argentina, United Arab Emirates, Chile and Lebanon.