Genzyme, a subsidiary of Sanofi, has received a Refuse to File letter from the US Food and Drug Administration (FDA) in response to the supplemental Biologics Licence Application (sBLA) for the approval of Lemtrada (alemtuzumab) as a treatment for relapsing multiple sclerosis (MS). Genzyme is developing Lemtrada in MS in collaboration with Bayer HealthCare.
After collaborative consultations with the FDA, the agency requested that the company modify the presentation of the data sets to enable the agency to better navigate the application. The FDA has not requested additional data or further studies. Genzyme will work with the FDA over the coming weeks to resubmit the application as soon as possible.
“We have had constructive dialogue with the FDA, and we are very confident in our ability to address the agency’s request and resubmit rapidly,” said David Meeker, president and CEO, Genzyme.
The company’s marketing authorization application submitted to the European Medicines Agency has been accepted and the review process is underway.
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 co-promote under this option. Upon regulatory approval and commercialization, Bayer would receive contingent payments based on sales revenue.
Lemtrada is the proprietary name submitted to health authorities for the company’s investigational multiple sclerosis agent alemtuzumab.
Genzyme has pioneered the development and delivery of transformative therapies for patients affected by rare and debilitating diseases and accomplish its goal through world-class research and with the compassion and commitment of our employees. The company has a focus on rare diseases and multiple sclerosis, and are dedicated to making a positive impact on the lives of the patients and families they serve.
Sanofi, a global and diversified healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. It 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.
Bayer HealthCare, a subgroup of Bayer AG is one of the world’s leading, innovative companies in the healthcare and medical products industry and is based in Leverkusen, Germany.