FDA accepts Merck KGaA oral MS Filing
The US Food and Drug Administration has accepted the resubmission of Merck KGaA’s New Drug Application (NDA) for cladribine tablets as a potential treatment for patients with relapsing forms of multiple sclerosis (MS) after finding a 2011 submission incomplete.
The US regulatory authority’s acceptance indicates that it has now found the drugmaker’s information sufficiently complete to permit a substantive review. Seven years ago, the FDA had issued a Complete Response Letter requesting an improved understanding of safety risks and the overall benefit-risk profile.
Commenting on the decision, Belén Garijo, CEO Healthcare at Merck KGaA, said the goal is to offer cladribine tablets to patients and physicians in the US as a new treatment paradigm for relapsing MS, and the company looks forward to working closely with the FDA throughout the review process.
Since August 2017, Merck’s cladribine tablets, sold under the trade name Mavenclad, have received regulatory approvals in 38 countries, including the EU, Canada, Australia, Israel, Argentina, United Arab Emirates, Chile and Lebanon. Additional filings in other countries are planned for 2018.
Cladribine tablets have 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 Darmstadt, Germany-based pharmaceuticals and chemicals group said.
While most available MS therapies require continued, regular dosing of medication, a treatment approach consisting of short, infrequent oral treatment cycles may help lower the treatment burden for patients, Merck quotes Thomas Leist, Director, Comprehensive Multiple Sclerosis Center at Jefferson University Hospitals in Philadelphia, Pennsylvania, as saying.
According to the German drugmaker, the NDA acceptance includes close to 12,000 patient years of data with over 2,700 patients included in the clinical trial program, and up to 10 years of safety data in some patients. The clinical development program included data from three Phase III trials and long-term follow-up data from an eight-year prospective registry.
For patients with highly active RMS as defined by clinical or imaging features, Merck has received approvals in the EU, Israel, Argentina, United Arab Emirates, Chile and Lebanon. In December 2017, Health Canada and the Therapeutic Goods Administration (TGA) in Australia approved the tablets for the treatment of relapsing-remitting MS (RRMS).
