Tascenso ODT launches in US with patient support program
The alternative to Gilenya is approved for MS patients, 10 and older
Tascenso ODT, an approved alternative to Gilenya (fingolimod), is now available to multiple sclerosis (MS) patients in the U.S., where it’s being marketed by Cycle Pharmaceuticals.
The launch comes about a month after the U.S. Food and Drug Administration approved a 0.5 mg dose of the therapy, making its indications the same as Gilenya’s.
Tascenso ODT is bioequivalent to Gilenya, meaning it contains the same active ingredient — fingolimod — and is absorbed in the body at similar concentrations and rates. It’s been shown to yield a comparable safety and efficacy profile.
Tascenso ODT tablets disintegrate on the tongue within seconds
However, the treatment is not considered a Gilenya generic, and the route of delivery between the two medications is different. While Gilenya comes in capsules and must be swallowed, Tascenso ODT is given as tablets that disintegrate on the tongue in a few seconds without the need for water. The medication can be taken with or without food and water, once daily.
“Tascenso ODT is the first orally disintegrating tablet, or ODT, approved to treat MS patients in the US,” John Reid, Cycle’s patient support director, said in a company press release. “We expect this ODT formulation to be an attractive option for MS patients looking for convenience, and testament to that, we are already receiving Tascenso ODT enrolment forms.”
The treatment was developed by Handa Neuroscience, which gave Cycle the rights to market the therapy in the U.S. Catalent’s Zydis technology was used to achieve the tablets’ quickly dissolving properties.
Gilenya and Tascensco ODT are approved for the same indications — children and adults, ages 10 and older, with relapsing types of MS: clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS.
Both are available in 0.25 mg and 0.5 mg dose strengths. Tascenco ODT’s 0.25 mg dose was approved in 2021 for pediatric patients, 10 and older, who weigh up to 40 kg (almost 90 pounds). The 0.5 mg dose was approved last month and is indicated for patients weighing 40 kg or more.
Tascenso ODT is the first orally disintegrating tablet, or ODT, approved to treat MS patients in the US.
Launch of Tascenso ODT includes patient support program, Cycle Vita
Tascenso ODT’s launch comes with a full patient support program called Cycle Vita. The program will offer similar support to the Gilenya GO program, which will be withdrawn on March 31.
Gilenya GO was created to offer patients ongoing support while using Gilenya, including educational resources, navigation of insurance coverage, and financial assistance. Its $0 copay program helped to keep the high-cost medication affordable for patients.
However, with the expected launch of Gilenya generics this year, Novartis will no longer offer the program, and will stop co-pay support at the end of year. Similar services aren’t currently available with generic fingolimod.
“For some of our patients, co-pay deductibles on generic fingolimod capsules are unaffordable, forcing switches to other treatments,” said Bruce A. C. Cree, MD, PhD, a professor of clinical neurology and clinical research director of the Weill Institute for Neurosciences at the University of California San Francisco.
Cycle hopes that Tascenso ODT and Cycle Vita will be a viable alternative for patients who are facing that choice.
“The launch of Tascenso ODT comes at a critical time for patients already on Gilenya or generic fingolimod therapy,” Reid said. “Ultimately this will ensure these patients can continue to access patient support services, remain on fingolimod and avoid potential disease advances and worry associated with discontinuing their current fingolimod treatment.”
In addition to its $0 co-pay program, Cycle Vita includes at-home assessments and first dose observation, medication adherence support, and a bridge program to facilitate the transition from other fingolimod products.