The Food and Drug Administration (FDA) has approved 3 applications for the first generics of fingolimod (Gilenya; Novartis AG, Basel, Switzerland) for treating relapsing forms of multiple sclerosis (MS) in adult patients.
Fingolimod is a sphingosine 1-phosphate receptor modulator indicated for treating clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive MS in people age 10 years or more.
“Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA,” said Janet Woodcock, MD, director, FDA Center for Drug Evaluation and Research. “Having access to affordable treatments is important for patients with conditions that require ongoing care. The FDA has a longstanding commitment to increasing patient access to lower-cost high-quality generic medicines.”
James Geyer, MD; and Thomas Patton, MD
Ilka Kleffner, MD; Catharina C. Gross, PhD; Marius Ringelstein, MD; Jörg Rehrmann, MD; Markus Kraemer, MD; and Jan Dörr, MD