The National Institute for Health and Care Excellence (NICE) has recommended natalizumab as an option for adults with highly active multiple sclerosis (MS), a move that expands the drug’s use in patients with the chronic autoimmune disease.
Two versions of natalizumab are set for use on the NHS following the decision – Biogen’s Tysabri and biosimilar Tyruko, the latter made by Sandoz. Tysabri is given as an injection, while Tyruko is administered as an infusion.
NICE’s recommendation is that the drug be used for patients with highly active relapsing-remitting (RR) MS – an aggressive form of the central nervous system (CNS) disease. Eligible patients are those whose MS remains highly active after a full course of at least one disease-modifying therapy (DMT), and for whom Mavenclad (cladribine) is not suitable.
MS is a lifelong condition affecting around 123,000 people and is around three times more common in women than men. An estimated 43,000 people have RRMS at any one time and thousands of these people will have highly active RRMS. Tysabri is already recommended in England for people with rapidly evolving severe RRMS.
Tysabri and Tyruko work by preventing immune cells from attacking myelin – the protective sheath that wraps neurons.
There is already a range of targeted treatments available on the NHS for RRMS patients. A prominent therapy is Roche’s Ocrevus (ocrelizumab), given as twice-yearly infusions or twice-yearly injections.
According to Ceri Smith, head of policy at the MS Society, natalizumab’s availability will particularly benefit pregnant women with the disease.
“Natalizumab is a highly effective treatment, and we’re really pleased that people with highly active relapsing MS who haven’t responded to previous DMTs will now have the option to take it. Our decision will particularly benefit people who want to start a family, as natalizumab can be taken during pregnancy, unlike other highly effective DMTs,” Smith commented.
NICE’s director of medicines evaluation, Helen Knight, said: “This recommendation means people living with highly active RRMS now have a meaningful additional treatment option. Having choice matters enormously to people managing a lifelong condition — it allows individuals and their clinicians to select the treatment that best fits their personal circumstances.”
Tysabri is one of Biogen’s top-selling drugs, generating $415.4m in revenue in 2024. The treatment saw peak sales of around $2bn in 2021, with revenue decreasing since due to competition from biosimilars.
