FDA Approves Tascenso ODT to Treat Multiple Sclerosis in Children

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December 23, 2021 – Tascenso ODTTM (fingolimod) orally disintegrating tablets have been approved to treat relapsing forms of multiple sclerosis (MS) in pediatric patients who are at least 10 years old and weigh less than or equal to 40kg (88 pounds). The indication includes clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease.

  • Fingolimod, the active pharmaceutical ingredient of Tascenso ODT, has been FDA approved to treat MS since 2010.
  • Recommended dosing for Tascenso ODT is 0.25mg taken by mouth once daily. The tablet is placed directly on the tongue and allowed to dissolve before being swallowed. Patients must be monitored in a healthcare setting for at least six hours when taking their first dose or when restarting the medication after not taking it for more than 14 days.
  • Pricing is not yet available from manufacturer Handa Neuroscience.