FDA awards first paediatric MS approval to Novartis' Gilenya

The FDA has awarded approval for what it says is its first drug for the treatment of multiple sclerosis (MS) in paediatric patients, giving the green light to Novartis’ Gilenya (fingolimod) specifically in relapsing forms of the disease following its designation as a Breakthrough Therapy last year.

The debilitating condition occurs more frequently in adults, but children and adolescents are more likely to experience more frequent brain lesions and relapses. Only around 2-5% of cases see a manifestation of symptoms before the patient reaches 18, with estimates suggesting that are between 8,000 and 10,000 paediatric cases of the condition in the US.

The regulator’s decision was based on Phase 3 data which showed that Gilenya reduced the rate of relapses by around 82% over a period of up to two years compared to interferon beta-1a intramuscular injections.

"For the first time, we have an FDA-approved treatment specifically for children and adolescents with multiple sclerosis," commented Dr Billy Dunn, Director of the Division of Neurology Products in the FDA's Center for Drug Evaluation and Research. "Multiple sclerosis can have a profound impact on a child's life. This approval represents an important and needed advance in the care of paediatric patients with multiple sclerosis."

Fabrice Chouraqui, US President of Novartis, added: "After becoming the first approved oral MS therapy in the US in 2010, we're proud this new approval represents another first for Gilenya. It is the latest achievement in our ongoing commitment to drive innovation in MS and bring additional treatment options to more patients, including young people with MS."

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