European regulators are a step closer towards licensing the first pill for multiple sclerosis (MS) in the European Union (EU). The Committee for Medicinal Products for Human Use (CHMP), an expert committee of the European Medicines Agency (EMA), adopted a positive opinion and recommended the approval of daily pill fingolimod 0.5 mg (Gilenya®). A UK licence is expected in the next few months.
The Committee recommended fingolimod 0.5 mg as a disease modifying therapy in patients with highly active relapsing-remitting multiple sclerosis (RRMS) despite treatment with beta interferon, or in patients with rapidly evolving severe relapsing-remitting MS.
Today’s decision makes fingolimod the first daily MS pill to be recommended for approval in the European Union and follows the approval of fingolimod in Russia and the United States. Until now, many people with MS have had to self inject at least weekly or travel to hospital for infusions.1,2
“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. Fingolimod halves the frequency of relapses compared to a commonly used injection (interferon β-1a), which means that people can get on with their lives. I look forward to fingolimod being available in the UK,” commented Dr Eli Silber, fingolimod clinical trial investigator and Consultant Neurologist who leads an MS service for South London based at King’s College.
The CHMP opinion was based on data from a large clinical trial programme, which has shown that fingolimod reduced relapses by 54% compared to placebo and reduced disability progression by a third.3 In addition, fingolimod is the only pill proven to be twice as effective at reducing rate of relapse as a commonly used intramuscular injection (interferon β-1a).4 The clinical trial programme also showed that treatment with fingolimod resulted in statistically significant reductions in brain lesion activity as measured by MRI.3,4 The clinical trial programme included eight hospitals in the UK.5,6
Fingolimod works differently to any other MS treatment by controlling immune cells that mistakenly attack the brain and spinal cord.7 These cells (lymphocytes) are retained in the lymph nodes (glands) to prevent them from causing damage.4,8,9,10 The key immune functions remain preserved, and importantly the retention of lymphocytes can be reversed thereby providing the flexibility to try other medicines if required by their healthcare professional.4,9
Fingolimod has a well-studied safety and tolerability profile, with more than 4,000 clinical trial patients.11
MS affects around 100,000 people in the UK and is typically diagnosed between 20-40 years of age, with women twice as likely to develop it than men.12
Source: Novartis