Lemtrada is Genzyme’s Second MS Treatment to Gain NHS Reimbursement Following Recent NICE Approval of Once-Daily, Oral Aubagio
May 27, 2014
Genzyme, a Sanofi company, announced today that the National Institute for Health and Care Excellence (NICE) issued final guidance recommending that Lemtrada™ (alemtuzumab) be reimbursed on the NHS, for treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features. A Final Appraisal Determination (FAD) issued earlier this year concluded Lemtrada is a cost-effective use of NHS resources for MS treatment, and formed the basis of the final guidance for reimbursement.
“The fact that NICE has followed the European Commission decision on patient eligibility for Lemtrada marks a step change in the clinical approach to treating MS,” said Dr. Alasdair Coles, Senior Lecturer, Department of Clinical Neurosciences, University of Cambridge. “With this final guidance, the responsibility for treatment decisions with Lemtrada is now handed over to UK healthcare professionals and their patients.”
The final guidance follows the European Commission’s granting of marketing authorization for Lemtrada in September 2013. Aubagio® became available on the NHS in April 2014.
“We are pleased that NICE has recommended Lemtrada as being both clinically effective and cost effective for people with relapsing remitting MS,” said David Meeker, President and CEO, Genzyme. “There are approximately 100,000 people in the UK diagnosed with the disease and Lemtrada can be a potentially transformative treatment for appropriate patients.”
Lemtrada is indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS) with active disease defined by clinical or imaging features. Lemtrada 12 mg has a novel dosing and administration schedule of two annual treatment courses. The first treatment course of Lemtrada is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later.
The Lemtrada clinical development program included two pivotal randomized Phase III studies comparing treatment with Lemtrada to high-dose subcutaneous interferon beta-1a (Rebif®) in patients with RRMS who had active disease and were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II), as well as an ongoing extension study. In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates; the difference observed in slowing disability progression did not reach statistical significance. In CARE-MS II, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a.
The most common side effects of Lemtrada are infusion associated reactions, infections (upper respiratory tract and urinary tract), lymphopenia and leukopenia. Serious autoimmune conditions can occur in patients receiving Lemtrada. A comprehensive risk management program supports early detection and management of these autoimmune events.
Aubagio 14 mg is a once-daily, oral therapy indicated for treatment of adult patients with RRMS. The EU approval was based on data from the Phase III TEMSO (TEriflunomide Multiple Sclerosis Oral) and TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis) trials.
About LemtradaTM (alemtuzumab)
Lemtrada is approved in the European Union, Australia, Brazil, Canada, Mexico and Guatemala. Lemtrada is currently not approved in the United States. Following constructive discussions with the FDA, Genzyme plans to resubmit in the second quarter of 2014 its application seeking U.S. approval of Lemtrada. Marketing applications for Lemtrada are also under review in other countries. Lemtrada is supported by a comprehensive and extensive clinical development program that involved nearly 1,500 patients and 5,400 patient-years of follow-up.
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 holds the right to co-promote alemtuzumab in MS in the United States. Upon commercialization, Bayer will receive contingent payments based on global sales revenue.
About Aubagio® (teriflunomide)
Aubagio is approved in the United States, European Union, Australia, Argentina, Brazil, Canada, Chile, Colombia, Mexico, New Zealand, South Korea and Switzerland, with additional marketing applications under review by regulatory authorities globally.
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). Aubagio is supported by one of the largest clinical programs of any MS therapy, with more than 5,000 trial participants in 36 countries. Some patients in extension trials have been treated for up to 10 years.
About Genzyme, a Sanofi Company
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases for over 30 years. We accomplish our goals through world-class research and with the compassion and commitment of our employees. With a focus on rare diseases and multiple sclerosis, we are dedicated to making a positive impact on the lives of the patients and families we serve. That goal guides and inspires us every day. Genzyme’s portfolio of transformative therapies, which are marketed in countries around the world, represents groundbreaking and life-saving advances in medicine. As a Sanofi company, Genzyme benefits from the reach and resources of one of the world’s largest pharmaceutical companies, with a shared commitment to improving the lives of patients. Learn more at www.genzyme.com.
Genzyme® and Aubagio® are registered trademarks and LemtradaTM is a trademark of Genzyme Corporation.
Rebif® is a registered trademark of EMD Serono, Inc.
Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).