FDA expands fingolimod's indications to treat relapsing MS in pediatric patients


Pediatric patients with multiple sclerosis will now have a treatment option in fingolimod (Novartis’ Gilenya).

The Food and Drug Administration approved on May 11 an expanded indication of the drug to allow it to be used to treat relapsing MS in children and adolescents age 10 and older. Gilenya was first approved by FDA to treat adults with relapsing MS in 2010.

“For the first time, we have an FDA-approved treatment specifically for children and adolescents with multiple sclerosis,” Billy Dunn, MD, director of the Division of Neurology Products in the FDA Center for Drug Evaluation and Research, said in a statement. “This represents an important and needed advance in the care of pediatric patients with multiple sclerosis.”

Side effects for fingolimod in pediatric trial participants were similar to those experienced in adults, the most common of which include headache, liver enzyme elevation, diarrhea, cough, flu, sinusitis, back pain, abdominal pain, and pain in extremities. The drug must be dispensed with a medication guide that describes the product’s more serious risks.

The FDA, which granted the product a priority review and breakthrough designation for this indication, noted that 2%-5% of people with MS have symptoms onset before age 18 and suggested that 8,000-10,000 children and adolescents in the United States suffer from the disease.

The clinical trial evaluating the drug included 214 patients aged 10-17 years and compared fingolimod with interferon beta-1a. In that study, the FDA stated that 86% of patients receiving fingolimod remained relapse-free after 24 months of treatment, compared with 46% of those treated with interferon beta-1a.

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