Removal of access to alemtuzumab for patients with aggressive multiple sclerosis

Although some treatments are now available for multiple sclerosis, better treatments are needed for people with aggressive disease. The need to find agents that can prevent or slow disease progression is particularly challenging and requires a concerted global effort that combines academic and pharmaceutical expertise. Although such partnerships are rare, the story of alemtuzumab has shown, inspirationally, that academic and pharmaceutical prowess can be combined to deliver an agent with real promise. Alemtuzumab, which has been used successfully off label to treat active relapsing-remitting multiple sclerosis, is a humanised monoclonal antibody that targets the CD52 antigen on leucocytes. Not surprisingly, there was therefore an outcry when Genzyme, now a Sanofi company, surrendered the licence for all currently licensed preparations of alemtuzumab, with effect from 8 August 2012, meaning that it will no longer be available as a licensed product in the United Kingdom once existing supplies run out.1 2

This withdrawal was not related to product safety, efficacy, or supply, but was part of Genzyme’s plans for bringing alemtuzumab forward as a treatment for multiple sclerosis. It was done in agreement with the Medicines and Healthcare Products Regulatory Agency …