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Last week, we reported on the US Food and Drug Administration (FDA) approval of natalizumab-sztn (Tyruko; formerly known as PB006), the first biosimilar to natalizumab (Tysabri; Biogen) injection for the treatment of adults with relapsing forms of multiple sclerosis (MS).
With this indication, natalizumab-sztn can be utilized for patients with clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease. Approval for the treatment was awarded to Sandoz.
Additionally, the biosimilar is indicated for inducing and maintaining clinical response and remission in adults with moderately to severely active Crohn disease who also have evidence of inflammation and have had an inadequate response or inability to tolerate conventional therapies and inhibitors of tumor necrosis factor.
The decision to approve was based on evidence showing no clinically meaningful differences between the Sandoz product and the already approved Biogen agent in terms of safety, purity, and potency. The treatment was assessed in the phase 3 Antelope study (NCT04115488), which included 264 participants, of which 131 received the biosimilar and 133 received the reference agent natatlizumab. At week 24, the model-based, least squares mean difference in cumulative number of new active lesions between biosimilar and reference treatment groups was 0.17. There were no significant differences between treatment groups observed across secondary efficacy end points, safety, tolerability, or immunogenicity assessments.
The most common adverse events associated with natalizumab products are headache and fatigue, with other common AEs including arthralgia, urinary tract infection, lower respiratory tract infection, gastroenteritis, vaginitis, depression, pain in extremity, abdominal discomfort, diarrhea, and rash.