Novartis Leads Drug Approval NewsBy
A roundup of the latest drug approvals, including from the pharmaceutical majors, featuring news from Novartis.
Editor’s Note: This article was updated on a continuous basis for news announced from Wednesday May 9, 2018 date to Tuesday May 15, 2018.
FDA OKs Novartis’ MS Drug Gilenya for Pediatric Use
The US Food and Drug Administration (FDA) has approved Novartis’ Gilenya (fingolimod) for treating children and adolescents 10 to less than 18 years of age with relapsing forms of multiple sclerosis (RMS).
This approval expands the age range for Gilenya, which was previously approved for treating patients aged 18 years and older with RMS. Gilenya was granted breakthrough therapy designation by the FDA in December of 2017 for this pediatric indication.
Gilenya is approved in the US for the first-line treatment of relapsing forms of MS, and in the European Union for adult patients with highly active relapsing-remitting MS (RRMS) defined as either high-disease activity despite treatment with at least one disease-modifying therapy, or rapidly-evolving severe RRMS.