Promising rheumatoid arthritis therapy sarilumab accepted for EU review

A potentially promising new treatment for rheumatoidarthritis has just passed an important milestone on its path to regulatory approval. Sarilumab, a human monoclonal antibody intended for the treatment of adults with moderate to severely activerheumatoid arthritis, has had its marketing authorisation application accepted by the European Medicines Agency (EMA), bringing it one step closer to widespread availability. The benefits of the new therapy Developed by Sanofi and Regeneron Pharmaceuticals, sarilumab works by targeting the IL-6 receptor, which is known to play a key role in the joint damage and painful symptoms that rheumatoid arthritis patients experience. The EMA - Europe's regulatory body for newdrugs - has agreed to consider the therapy for approval based on the positive results from seven clinical trials involving more than 3,300 adults, the majority of whom were not able to benefit from existing types of therapy such as disease-modifying anti-rheumatic drugs (DMARDs) or anti-TNFs. In one of these studies, 61 per cent of patients taking sarilumab in combination with DMARDs showed a 20 per cent improvement in their arthritis after 24 weeks. The treatment has also shown a strong safety performance in the studies completed so far. An important regulatory milestone Now that the EMA has accepted the marketing authorisation application for this drug, its experts will consider the data submitted by the manufacturers and determine whether or not the therapy is safe an...
Source: Arthritis Research UK - Category: Rheumatology Source Type: news