The Food and Drug Administration (FDA) has approved the first generic versions of Gilenya (fingolimod; Novartis) for the treatment of relapsing forms of multiple sclerosis in adults.
The approvals were granted to HEC Pharm Co. Limited, Biocon Limited and Sun Pharmaceutical Industries Limited; all 3 companies received approval to manufacture the 0.5mg capsule strength. Gilenya is also available as a 0.25mg capsule, however this dosage strength was not included in the application.
Like the brand, fingolimod capsules must be dispensed with a Medication Guide outlining potential adverse events including an increased risk of infections and the possibility of progressive multifocal leukoencephalopathy (PML), among others.
“Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA,” said Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research. “Having access to affordable treatments is important for patients with conditions that require ongoing care.”
Fingolimod is a sphingosine 1-phosphate receptor modulator. The mechanism by which fingolimod exerts therapeutic effects in multiple sclerosis is unknown, but may involve reduction of lymphocyte migration into the central nervous system. In 2018, the FDA issued a safety communication alerting healthcare professionals about the potential risk of severe increase in disability following discontinuation of fingolimod therapy.
For more information visit fda.gov.