Posted from: Monday, June 04, 2018 - 10:24 AM - Present

Gilenya Receives Pediatric Indication for Multiple Sclerosis

May 11, 2018 – The U.S. FDA has approved a new indication for Gilenya® (fingolimod), manufactured by Novartis, to treat patients at least 10 years of age who have relapsing multiple sclerosis (MS). This is the first FDA drug approval granted for a pediatric MS indication.

In clinical trials, 86% of patients age 10 to 17 years remained relapse-free on Gilenya for 24 months, versus 46% of patients in the same age range who received interferon beta-1a to treat MS. Patients in the trial experienced side effects comparable to those seen in adults who use Gilenya, including flu, headache, abdominal pain, back pain, diarrhea, sinusitis, and elevated liver enzymes.

Multiple sclerosis affects an estimated 8,000 to 10,000 children in the United States. Children with the condition may experience more frequent relapses and develop more brain lesions than adults. Over time, recovery following relapse becomes incomplete, leading to more lasting damage and increasing levels of disability.

Gilenya first won FDA approval in 2010 to treat adults diagnosed with relapsing MS. At the time, it was the first oral therapy approved for the treatment of MS.

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Last Updated Wednesday, August 15, 2018 - 01:02 PM.