The US Food and Drug Administration (FDA) has accepted for review the Genzyme's supplemental Biologics License Application (sBLA) file seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing multiple sclerosis (RMS). The company also reported key highlights from the US launch of once-daily, oral Aubagio (teriflunomide).
The FDA has accepted for standard review the company’s sBLA file seeking approval of Lemtrada.
Genzyme expects FDA action on the application in the second half of 2013. Genzyme has already submitted its marketing authorization application for Lemtrada to the European Medicines Agency (EMA) and the review process is underway. The Committee for Medicinal Products for Human Use (CHMP) opinion for Lemtrada is expected in Q2 2013.
The Lemtrada clinical development programme includes CARE-MS I and CARE-MS II (Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis), randomized Phase III studies comparing
Lemtrada to a standard of care MS treatment, Rebif, in patients with relapsing-remitting MS who were naïve to prior treatment or who had relapsed while on prior therapy, respectively. Genzyme announced publication of results of these studies in The Lancet in November 2012.
Since its launch in October, once-daily, oral Aubagio has shown very encouraging early launch indicators among US prescribers.
“Genzyme is making a difference for people living with MS and realizing its vision of being leaders in MS,” said Genzyme president and CEO, David Meeker, M.D. “The initial uptake of Aubagio by US prescribers shows the importance of a once-daily oral option in MS. In addition, the acceptance of the Lemtrada file in the US marks another important milestone in bringing this potentially transformative therapy to MS patients. We look forward to a series of product launches in 2013 in Europe and other major markets.”
Aubagio is approved for use in both the US and Australia.
Alemtuzumab 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 multiple sclerosis. Bayer HealthCare retains an option to co-promote alemtuzumab in multiple sclerosis. Bayer HealthCare has notified Genzyme of its intention to copromote under this option. Upon regulatory approval and commercialization, Bayer would receive contingent payments based on sales revenue.
Aubagio is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Aubagio is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS).