Disease modifying therapies for MS with a positive opinion regarding marketing authorisation from the European Marketing Agency (EMA)
| Drug | Registered trade name | Date of current EU marketing licence | Approved indication | NICE approval | Administration | Most common or serious side effects |
|---|---|---|---|---|---|---|
| Interferon-β 1a | Rebif | 4 May 1998 | Relapsing–remitting MS | No | sc x3 per week | Hypersensitity reactions, mood disturbance, liver toxicity, blood disorders, thyroid disease, ‘flu-like symptoms and injection site reactions including lipodystrophy. Neutralising antibodies may develop in up to one-third patients |
| Interferon-β 1a | Avonex | 13 March 1997 | Relapsing–remitting MS or a single demyelinating event with an active inflammatory process (severe enough to warrant iv corticosteroid and patient is at high risk of developing MS) | No | im weekly | |
| Interferon-β 1b | Extavia | 20 May 2008 | Relapsing–remitting MS or progressive MS with active disease or for a single demyelinating event with an active inflammatory process (if severe enough to require iv corticosteroid and patient at high risk for developing MS) | No | sc alternate days | |
| Interferon-β 1b | Betaferon/Betaseron | 30 November 1995 | Relapsing–remitting MS or progressive MS with active disease or for a single demyelinating event with an active inflammatory process (if severe enough to require iv corticosteroid and patient at high risk for developing MS) | No | sc alternate days | |
| Glatiramer acetate | Copaxone | 23 December 1996 | UK Initial symptoms in patients at high risk of developing MS and reducing the frequency of relapses in ambulatory patients with relapsing–remitting MS with at least 2 clinical relapses in the past 2 years | No | sc daily | Hypersensitity reactions, mood disturbance, flu-like symptoms, injection site reactions including lipodystrophy |
| Natalizumab | Tysabri | 27 June 2006 | UK Highly active relapsing–remitting MS despite treatment with interferon β or rapidly evolving severe relapsing–remitting MS | Yes | iv every 4 weeks | Risk of PML increases after 2 years of therapy. Hypersensitivity reactions and liver toxicity |
| Fingolimod | Gilenya | 17 March 2011 | UK Highly active relapsing–remitting MS despite treatment with interferon β or in those with rapidly evolving severe relapsing–remitting MS | Yes | po x1/day | AV block, mood disturbance, headache, nasopharyngitis, fatigue, lymphopenia, liver abnormalities, dyspnoea and macular oedema. Herpes viral infections. Possible increased risk of lymphoma and other malignancies |
| Dimethyl fumarate | Tecfidera | Awaited following recommendation for approval from EMA 21 March 2013 | Adults with relapsing–remitting MS | Not yet known | po x2–3/day | Flushing, gastrointestinal upset, lymphopenia, elevated liver enzymes |
| Teriflunomide | Aubagio | Awaited following recommendation for approval from EMA 21 March 2013 | Adults with relapsing–remitting MS | Not yet known | po x1/day | Upper respiratory tract infections, urinary tract infections, diarrhoea, nausea, paraesthesia, alopecia and increase in the liver enzyme alanine aminotransferase. Possible teratogenetic effect with the potential for on-going effects postcessation of therapy |
| Alemtuzuamab | Lemtrada | Awaited following recommendation for approval from EMA 27 June 2013 | Adults with relapsing–remitting MS, with active disease defined by clinical or imaging features | Not yet known | iv 12 mg daily for 5 days with further 3-day course >1 year later | Infusion reactions, lymphopenia, autoimmune disease including ITP and thyroid disease, infection |
Definition of relapsing–remitting MS for the purposes of drug licensing in the UK: patient has demyelinating disease with at least two attacks over the previous 2–3 years and who is able to walk unaided.
AV, atrioventricular; im, intramuscularly; ITP, idiopathic thrombocytopenic purpura; iv, intravenously; MS, multiple sclerosis; NICE, National Institute for Health and Care Excellence; PML, progressive multifocal leucoencephalopathy; po, oral; sc, subcutaneously.