FDA Expands Use of Gilenya® (fingolimod) for Children and Teens 10 Years and Older with Relapsing MS - First Approved Therapy for Pediatric

[bxrmom]

May 11, 2018

Updated 5/17/18

SUMMARY

The U.S. Food and Drug Administration has approved the expansion of the use of the oral MS therapy Gilenya® (fingolimod, Novartis AG) to include the treatment of children and adolescents 10 years of age or older with relapsing MS.

This is the first therapy specifically approved to treat pediatric MS.

A large phase 3 clinical trial showed benefits in reducing relapses and disease activity on MRI.

The most common side effects were headache, liver enzyme elevation, diarrhea, cough, flu, sinusitis, back pain, abdominal pain and pain in extremities. A Medication Guide will help inform patients and their families about its use and potential risks.

For more information, contact the Gilenya Go Program online or by phone 1-800-GILENYA (1-800-445-3692)

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[kdali]

Aww, great news! I wonder if we have many members that were diagnosed as children?

[MS_Indestructible in reply to kdali]

I should have been, but not dx till I was 48 ~terry