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.2
TASCENSO ODT is bioequivalent to Gilenya capsules and it has the same safety, efficacy and side effects.1 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.2
Chikai Lai, Deputy CEO of Cycle commented: “We’re thrilled that the FDA has approved TASCENSO ODT for MS patients. This will allow patients who were facing a switch to a different disease modifying therapy following the withdrawal of patient support services around Gilenya, to remain on fingolimod and avoid any potential side effects, disease advances and worry that can arise when discontinuing or switching treatment.”
Lai added: “We created Cycle Vita, as our dedicated hub program to deliver individualized product support, and are delighted to offer this to eligible MS patients.* We believe that this wider offering will help any patients transitioning to TASCENSO ODT in 2023 to do so as seamlessly as possible with maximum support.”
Dr Jon Santoro, MD, Associate Professor of Neurology and Pediatrics, Keck School of Medicine of the University of Southern California and Director of Neuroimmunology, Children’s Hospital Los Angeles, stated: “I’m incredibly pleased that eligible persons with MS will be able to continue to be treated with fingolimod, via TASCENSO ODT, where appropriate, meaning that their ongoing therapy remains consistent. This will reduce therapeutic uncertainty given the potentially challenging circumstances they could have faced had an alternative bioequivalent not been made available.”
MS affects an estimated 1 million people in the US with around 200 new cases being diagnosed each week.3 Approximately 85% of diagnoses are the relapsing-remitting form of the condition and without treatment about 50% of those progress to the more serious secondary-progressive form within 10 years.3 Around 100,000 MS patients in the US have been treated with Gilenya.4
Cycle expects to make TASCENSO ODT available to eligible patients in February 2023. To find out more about TASCENSO ODT and Cycle Vita please visit www.tascenso.com and www.cyclevita.life respectively.
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