First Natalizumab Biosimilar Approved By The FDA For The Treatment Of MS

5 Sept 2023 • Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab), was approved by the U.S. Food and Drug Administration for the treatment of individuals with relapsing types of multiple sclerosis (MS). Like Tysabri, Tyruko is also indicated for inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease (CD).

Natalizumab-sztn has been approved to treat the following relapsing forms of MS:

  • Clinically isolated syndrome
  • Relapsing-remitting disease
  • Active secondary progressive disease

It has been established as a biosimilar to Tysabri (natalizumab) based on evidence that showed there are no clinically significant differences between the two products in terms of safety, purity and potency (i.e., safety and effectiveness).

Natalizumab products (including Tyruko and Tysabri) contains a boxed warning regarding the elevated risk of PML . Risk factors for the development of PML include the presence of anti-JCV antibodies, longer duration of therapy and prior use of immunosuppressants.

These factors should be taken into account in the context of anticipated benefit when initiating and continuing treatment with natalizumab products. Source: FDA | Read full story

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