Gilenya, marketed by Novartis, is an oral disease-modifying treatment for relapsing MS. It acts by binding and modulating receptors — called the sphingosine-1-phosphate receptor — on immune system cells called lymphocytes.
Gilenya prevents lymphocytes from leaving the lymph nodes and reaching the brain and spinal cord to lower lymphocyte-induced inflammation and damage.
The therapy was approved for adults with relapsing MS by the U.S. Food and Drug Administration in 2010, and the FDA expanded Gilenya’s approval to treat pediatric relapsing MS patients starting at age 10 in May 2018.
Its decision was based on data from the Phase 3 PARADIGMS study (NCT01892722) that compared the safety and effectiveness of two doses of oral Gilenya each day — either 0.5 or 0.25 mg — to a weekly intramuscular injection of Avonex (interferon beta-1a, marketed by Biogen) in young patients. Treatment was given for up to two years.
Results showed that Gilenya reduced by almost 82% the frequency of MS flares in pediatric patients compared to Avonex. A majority, 85.7%, of Gilenya-treated patients were relapse-free at two years compared to 38.8% of those given Avonex.
Those treated with Gilenya also had a significantly reduction, by 53%, in the number of new or newly enlarged brain lesions, and the average number of lesions per scan at two years was reduced by 66% when compared to Avonex.
Gilenya also significantly lowered the annual rate of brain shrinkage, or atrophy, by 40%.
“I am delighted that we can now offer Gilenya to doctors and patients in China. There is a considerable need for MS treatments in China and we strive to bring clinical benefit to many patients with multiple sclerosis and improve their quality of life,” Ingrid Zhang, president, Novartis Pharmaceuticals China, said in a press release.
Around 30,000 people in China are thought to have MS.
“It is exciting news for MS patients in China that Gilenya has received fast approval. The approval of Gilenya and the upcoming regulatory review for Mayzent [also marketed by Novartis, and prevents lymphocytes from reaching the brain] demonstrate our commitment to Chinese patients,” said Marie-France Tschudin, president, Novartis Pharmaceuticals.
“We are proud that Gilenya already demonstrated its benefits to over 283,000 MS patients worldwide,” Tschudin added.