Sanofi to Resubmit sBLA for MS Drug LemtradaBy
Sanofi and its subsidiary Genzyme report that following discussions with FDA, the company plans to resubmit in the second quarter its supplemental biologics license application seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis (MS). The resubmission will provide information to specifically address issues noted by the FDA in its December 27, 2013 Complete Response Letter.
A Complete Response Letter informs companies that an application is not ready for approval. FDA had taken the position that Genzyme had not submitted evidence from adequate and well-controlled studies that demonstrate the benefits of Lemtrada outweigh its serious adverse effects. The decision was related to the design of completed Phase III active comparator studies of Lemtrada in relapsing-remitting MS patients. In the Complete Response Letter, FDA had taken the position that one or more additional active comparator clinical trials of different design and execution are needed prior to the approval of Lemtrada.
Genzyme had previously announced its intention to appeal the FDA's Complete Response Letter. In light of the planned resubmission, the company does not expect to pursue an appeal at this time.
Lemtrada is approved in the European Union, Canada, and Australia. It is a monoclonal antibody that selectively targets CD52, a protein abundant on T and B cells. Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab has minimal impact on other immune cells. The acute anti-inflammatory effect of alemtuzumab is immediately followed by the onset of a distinctive pattern of T and B cell repopulation that continues over time, rebalancing the immune system in a way that potentially reduces MS disease activity.
Genzyme holds the worldwide rights to alemtuzumab and has primary responsibility for its development and commercialization in MS. Bayer HealthCare retains an option to co-promote alemtuzumab in multiple sclerosis. Bayer HealthCare has notified Genzyme of its intention to co-promote under this option. Upon regulatory approval and commercialization, Bayer would receive contingent payments based on sales revenue.