FDA approves fingolimod bioequivalent for relapsing MS

Cycle Pharmaceuticals announced that the FDA has approved its Tascenso ODT, a bioequivalent to Gilenya, or generic fingolimod, for patients with relapsing forms of MS.

According to a company release, Cycle also will provide access to patient support services with its bioequivalent.

Novartis’ website states that the company will end its prescription co-pay patient support program for Gilenya March 31, 2023.

“We’re thrilled that the FDA has approved Tascenso ODT for MS patients,” Chikai Lai, Cycle deputy CEO, stated in the release. “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.”

According to the release, Tascenso ODT (fingolimod, Cycle) is a sphingosine 1-phosphate receptor modulator approved for treating relapsing-remitting MS, clinically isolated syndrome and active secondary progressive disease in patients aged 10 years and older.

Cycle’s fingolimod, available in 0.25 mg and 0.5 mg doses, has the same safety, efficacy and side effects profile as Gilenya capsules but is offered in a once-daily, orally disintegrating tablet that that can administered without food and water and dissolves within seconds, the company 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,” Jonathan D. Santoro, MD, assistant professor of clinical neurology and pediatrics at the University of Southern California Keck School of Medicine and director of neuroimmunology and demyelinating disorders at Children’s Hospital Los Angeles, said in the release. “This will reduce therapeutic uncertainty given the potentially challenging circumstances they could have faced had an alternative bioequivalent not been made available.”

Cycle plans to make Tascenso ODT available to eligible patients in February 2023, the release stated.

Reference:

• Frequently asked questions about Gilenya and generic fingolimod. https://www.gilenyahcp.com/frequently-asked-questions#:~:text=Yes%2C%20GILENYA%20will%20still%20be,medical%20co-pay%20card%20support. Updated August 2022. Accessed Jan. 19, 2023.