FDA Accepts Restitution of NDA for Oral Cladribine in Recurrent MS

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July 30, 2018

The Agency found the new submission sufficiently complete for a substantive review "title =" The Agency found the new submission sufficiently complete for a substantive review "border = "0" /> <p> The Agency ruled that the new submission was sufficiently complete for a thorough review </p> </p></div> <p> EMD Serono announced that the Food and Drug Administration (FDA) has accepted the new submission of the New Drug Application (NDA ) for cladribine tablets with relapsing multiple sclerosis (MS). </p> <p> The NDA's new submission follows the FDA's full response letter issued in 2011 that called for a better understanding of the security risks and the overall risk-benefit profile. The NDA contains data on nearly 12,000 patient-years among more than 2,700 patients included in the Phase 3 clinical program (CLARITY, CLARITY EXT and ORACLE MS), ONWARD Phase 2 study and follow-up data at long term of the 8 PREMIERE study. The submission also includes safety data for up to 10 years in some patients. The Agency found the new submission sufficiently comprehensive for a substantive review. </p> <p> Cladribine is approved under the trademark Mavenclad in 38 countries. In the United States, the experimental tablets are being studied as short-term oral therapy (treatment of 20 days maximum over 2 years) for recurrent MS. The drug is supposed to selectively target lymphocytes, which may be critical in the pathology of recurrent MS. </p> <p> "A treatment approach consisting of brief and infrequent oral treatment cycles can help ease the burden of treatment for patients," said Thomas Leist, MD, PhD, director of the Multiple Sclerosis Center for Hospitals Jefferson University. "Based on additional clinical research in recent years, we know more about the evolution of treatment, the safety and impact of cladribine tablets on several key measures of MS, and we hopefully it will be made available to the American community. " </p> <p> More information call (888) 275-7376 or visit EMDSerono.com </p> <p> <!-- LYTICS RECOMMENDED ARTICLE --><br /> <!-- END LYTICS RECOMMENDED ARTICLE --></p> <p> <!-- View Count --><br /> <img decoding=

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