The first generics of Gilenya have been approved by the FDA

The US Food and Drug Administration (FDA) has approved three applications for the first generics of Novartis‘ Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients.

“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. The FDA has a longstanding commitment to increasing patient access to lower-cost, high-quality generic medicines.”

MS is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For most people with MS, episodes of worsening function and appearance of new symptoms, called relapses or flare-ups, are initially followed by recovery periods (remissions). Over time, recovery may be incomplete, leading to a progressive decline in function and increased disability. 

Gilenya is a widely used orally administered treatment option for MS, with the most common side effects reported in the clinical trials for the treatment including headache, elevation of liver enzymes, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain and pain in the extremities.

The FDA has said that fingolimod must be dispensed with a Medication Guide that contains important information about its uses and risks.

The FDA has granted approvals of generic fingolimod applications to HEC Pharm Co. Limited, Biocon Limited and Sun Pharmaceutical Industries Limited.