Research & Development
Novartis awarded US FDA's approval for Gilenya as the first disease-modifying therapy in pediatric relapsing multiple sclerosis
14 May 2018 -

Healthcare company Novartis Pharmaceuticals Corporation revealed on Friday the receipt of approval from the US Food and Drug Administration (FDA) for Gilenya (fingolimod) for the treatment of children and adolescents with relapsing forms of multiple sclerosis.

This US FDA's approval for Gilenya (fingolimod) makes it the first disease-modifying therapy indicated in children and adolescents from ten to less than 18 years of age, with relapsing forms of multiple sclerosis. Gilenya was granted Breakthrough Therapy designation by the US FDA in 2017 for this pediatric indication. The children and adolescents with the chronic disease often experience more frequent relapses and brain lesions than adults with MS, said the company.

The company disclosed the US FDA approval expands the age range for Gilenya, which was previously approved for patients aged 18 years and older with RMS.

Approved for first-line use, Gilenya is a disease-modifying prescription therapy (DMT) that offers freedom from injections, which may fit many patients' lifestyles. Gilenya decreases the frequency of MS flare-ups (relapses) and helps slow down the physical problems caused by RRMS, stated the company.

In conjunction, the approval of Gilenya for the younger patient population was supported by the company's double-blind, randomized, multi-centre Phase III PARADIGMS study of fingolimod vs interferon beta-1a, designed for children and adolescents with RMS. The primary endpoint demonstrated that fingolimod reduced the annual relapse rate by 82% over a period of up to two years compared to interferon beta-1a intramuscular injections.

Multiple sclerosis (MS) is a chronic disorder of the central nervous system (CNS) that disrupts the normal functioning of the brain, optic nerves and spinal cord through inflammation and tissue loss.



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