European Commission reverses decision on drug, following QMUL research

12 September 2017

Source Queen Mary University of London:

A drug for multiple sclerosis (MS) has been granted a license by the European Commission, following evidence from Queen Mary University of London (QMUL) that it improves patients’ quality of life and is safer than previously thought.

MS is a degenerative disease of the central nervous system affecting more than 120,000 people in the UK and 2.5 million people globally, leading to disability and significant loss of quality of life.

The CLARITY trial, which ran from 2005 to 2009, was the largest ever trial of the drug Cladribine in people with relapsing MS, involving 1,326 patients. The results found that Cladribine was highly effective in controlling relapses, lesions in the brain and the progression of disability.

Cladribine also has advantages over other MS treatments in that it does not appear to be associated with severe adverse effects, including opportunistic infections and secondary autoimmune diseases.

For a number of reasons, including a perceived increase in cancer risk, the European Medicines Agency (EMA) rejected licence applications from the drug manufacturer, prompting a halt in commercial development of the drug in 2011. This was followed by the withdrawal of the drug from markets where it had been licensed (Russia and Australia) and ongoing trials were terminated.  Read on. 


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