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TASCENSO ODT approved by the US FDA

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    TASCENSO ODT approved by the US FDA

    TASCENSO ODT is now approved by the US Food and Drug Administration (FDA) as a bioequivalent to Gilenyaź (fingolimod)1, for which patient support program will be withdrawn in 2023.

    Cycle Pharmaceuticals Ltd (Cycle) has today welcomed the news that multiple sclerosis (MS) patients in the US currently being treated with Gilenya, or generic fingolimod to have access to appropriate patient support services alongside the bioequivalent, TASCENSO ODT1 following the withdrawal of Gilenya patient support on March 31st 2023.

    Cycle’s TASCENSO ODT has now been approved by the FDA for the treatment of relapsing forms of multiple sclerosis (RRMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older, and is available in 0.25 mg and 0.5 mg doses.

    TASCENSO ODT is bioequivalent to Gilenya capsules and it has the same safety, efficacy and side effects. However, Cycle’s unique formulation as a once-daily orally disintegrating tablet (ODT) means that it can be taken with or without food and water and dissolves on the tongue in seconds.

    https://www.yahoo.com/now/multiple-s...173800243.html
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