NVS Novartis AG

   By Donato Paolo Mancini 
 

Novartis's (NOVN.EB) multiple sclerosis drug Gilenya has been approved for use in pediatric patients by the U.S. Food and Drug Administration, the company and the regulator said.

The drug, previously approved for patients older than 18, is the first disease-modifying therapy indicated for individuals aged between 10 and 18.

Last Friday's approval comes after a phase 3 clinical trial showed Gilenya reduced relapse rates by approximately 82% over two years compared with interferon injections, the FDA said.

MS is mostly diagnosed in adults, although children and adolescents diagnosed with the disease tend to experience more frequent relapses.

The drug had been granted priority review and breakthrough therapy designation by the FDA last December, facilitating review and approval.

Novartis said last month first-quarter sales of the drug grew 8% to $821 million, with approximately 231,000 patients treated worldwide.

Write to Donato Paolo Mancini at donatopaolo.mancini@dowjones.com

(END) Dow Jones Newswires

May 14, 2018 01:29 ET (05:29 GMT)

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