FDA approves Novartis’ Gilenya for paediatric use

US regulators have approved Novartis’ Gilenya to treat children and adolescents with relapsing forms of multiple sclerosis (RMS), making it the first disease-modifying therapy indicated for this patient group.

The approval is based on a Phase III study involving patients with RRMS aged 10 to less than 18 years of age, which showed that Gilenya (fingolimod) cut the annualised relapse rate by around 82 percent versus interferon beta-1a injections.

Also, the drug’s safety profile was found to be overall consistent with that seen in previous clinical trials in adults.

Gilenya was first approved in the US in 2010 for the first-line treatment of relapsing forms of MS in adults and in the EU for adult patients with highly-active relapsing-remitting MS.

Commonly diagnosed during adolescence, paediatric MS is associated with relapses that are more frequent and often more severe than those seen in adults with the condition.

"We have eagerly anticipated a proven treatment option for younger people living with MS," said Elin Phillips, president, Pediatric Multiple Sclerosis Alliance. "Until now, there have been no large clinical trials to assess treatment efficacy of disease-modifying therapies in children and adolescents."

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