FDA Approves Tyruko for Multiple Sclerosis and Crohn’s Disease Treatment

Medication offers options to those who have relapsing forms of the disease.

The U.S. Food and Drug Administration (FDA) has authorized Tyruko (natalizumab-sztn), the first biosimilar to Tysabri (natalizumab) injection for treating adults with multiple sclerosis (MS). Tyruko serves the same purpose as Tysabri, including inducing and maintaining clinical response and remission in adult patients with moderately to severely active Crohn’s Disease (CD), who have shown inadequate responses to conventional therapies.

“Biosimilar medications offer additional effective treatment options that have the potential to increase access for people living with relapsing forms of multiple sclerosis,” said FDA’s Center for Drug Evaluation and Research Division of Neurology II Director Paul Lee. “Today’s approval could have a meaningful impact for patients managing their disease.”

Biosimilars are biological products closely resembling already approved reference products. Although MS involves episodes of symptom worsening and recovery, it can lead to progressive disability over time. These products are subject to a restricted distribution program, including a risk evaluation and mitigation strategy to monitor and manage potential risks, with regular evaluations for patients and healthcare providers.

As the Lord Leads, Pray with Us…

  • For discernment for Director Lee as he oversees the Division of Neurology II in the Food and Drug Administration’s Drug Evaluation and Research office.
  • For Commissioner Robert Califf to seek God’s direction as he heads the FDA.
  • For Americans who are living with MS and Crohn’s Disease.

Sources: Food and Drug Administration


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