Ozanimod (Zeposia) recommended for European licence

The European Medicines Agency (EMA) has recommended that a licence should be granted for ozanimod (Zeposia) for people with active relapsing remitting MS. Active is defined as people who are having relapses or have new or enlarging lesions on MRI scans.

The next step in the approval process is for the European Commission to grant the licence, taking into consideration the EMA's recommendation. Ozanimod will then be appraised by NICE and SMC to determine availability in the UK.

NICE has started the appraisal process for ozanimod but has put further work on hold to prioritize support for the coronavirus pandemic. The MS Trust is contributing to the appraisal.

About ozanimod

Ozanimod is taken as a tablet, once daily. A low dose is taken initially which is gradually increased over the first week. This reduces the risk of slowing the heart rate.

In a two year clinical trial, ozanimod reduced the risk of relapses by 38% compared to beta interferon (Avonex) and reduced the number of new active lesions seen on MRI.

The most common side effects reported in clinical trials were nasopharyngitis (common cold), reduced white blood cell count, headache, chest infections and urinary tract infections. Ozanimod caused temporary increases in liver enzymes which generally returned to normal levels without the need to stop treatment.

Ozanimod belongs to the same class of drugs as Gilenya (fingolimod). It works by retaining lymphocytes (immune cells) in lymph nodes. The number of lymphocytes reaching the brain is decreased, resulting in a reduced immune attack on nerve cells in the brain and spinal cord.