Multiple approvals for Novartis' MS drug

Novartis has received approval from Swissmedic, the Swiss Agency for therapeutic products, and the Australian Therapeutic Goods Administration (TGA) for Gilenya (fingolimod) 0.5 mg as a first-line, oral disease-modifying therapy (DMT) for the treatment of relapsing-remitting multiple sclerosis (RRMS).

The Committee for Medicinal Products for Human Use (CHMP), an expert committee of the European Medicines Agency (EMA), has adopted a positive opinion and recommended the approval of Gilenya 0.5 mg. A UK licence is expected in the next few months.

Gilenya is already approved in the US and Russia and has been filed with health authorities worldwide.

"MS is an unpredictable condition. People with MS live with the uncertainty of not knowing when a relapse will next strike; causing distress and affecting work and family life. Some people recover from the relapses, others do not, which contributes to disability." said Dr Eli Silber, fingolimod clinical trial investigator and consultant neurologist who leads an MS service for South London based at King's College.  

The Gilenya approvals and CHMP opinion were based on data from a large clinical trial programme showing that Gilenya reduced relapses by 52 per cent at one year when compared with interferon beta-1a IM, an approved first-line DMT. The data also showed a 54 per cent reduction in relapses at two years compared with placebo.

The trial data also showed that patients receiving Gilenya had a 30 per cent lower risk of disability progression, confirmed after three months and a 37 per cent lower risk of disability progression, confirmed after six months. Gilenya has a well-studied safety and tolerability profile and has been tested on more than 4,000 clinical trial patients worldwide.

Gilenya works differently to any other MS treatment by controlling immune cells that mistakenly attack the brain and spinal cord. These cells (lymphocytes) are retained in the lymph nodes (glands) to prevent them from causing damage. 

MS affects around 100,000 people in the UK and around 2.5m people globally. It is typically diagnosed between 20-40 years of age, with women twice as likely to develop the condition than men. MS is potentially the most common cause of non-traumatic, neurological disability in young adults.