MS drug approved for use in EU
A new treatment for multiple sclerosis has been approved by the European Medicines Agency, while reviewers have called for more evidence on another drug for the condition.
The EMA this week approved alemtuzumab, to be known by the brand name Lemtrada and previously called Campath-1H, for the treatment of MS in European Union countries.
The approval is the culmination of nearly three decades of research at the University of Cambridge.
Alemtuzumab reboots the immune system by first depleting a key class of immune cells, called lymphocytes. The system then repopulates, leading to a modified immune response that no longer regards myelin and nerves as foreign.
But after treatment with the drug, roughly one third of MS patients go on to develop another autoimmune disease that mainly targets the thyroid gland and more rarely other tissues especially blood platelets.
Researchers are currently investigating how to identify people who are susceptible to this side-effect and whether it can be prevented.
Although approved for use in EU, the drug has not yet been assessed by the National Institute for Health and Care Excellence for the treatment of MS.
NICE announced this week that it was also calling for more information on another MS drug, teriflunomide (Aubagio) before it decides whether to recommend the drug or not.
In draft guidance published for consultation, NICE has requested a series of clarifications on the evidence submitted by the drug’s manufacturer Genzyme.
NICE chief executive Sir Andrew Dillon said: “When reviewing the evidence for teriflunomide, the appraisal committee concluded that there were still questions to be answered about the effectiveness of the drug for adults with relapsing-remitting multiple sclerosis. This is why we have requested more details from the manufacturer.”
The manufacturer has until 8 October 2013 to submit this extra information to NICE. The committee will then review the extra evidence and develop further draft guidance.
Final guidance on the use of teriflunomide as a treatment for relapsing-remitting multiple sclerosis is expected to be published in January 2014.