FDA Approves Generic Versions of Gilenya®

Reviewed by MSAA Chief Medical Officer Barry A. Hendin, MD

On December 5, 2019, the United States Food and Drug Administration (FDA) announced that they had approved the applications from three separate pharmaceutical companies for the first generic versions of Gilenya® (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients. Approved in September 2010, Gilenya was the first oral drug available for the long-term treatment of relapsing-remitting MS.

Generic treatments carry the same benefits and risks of the initially approved medication. While this medication has been shown to slow disease activity, such as reducing the frequency of relapses as well as reducing the number of lesions as shown on magnetic resonance imaging (MRI), Gilenya’s potential side effects and adverse events include a temporary slowing of the heart rate, edema (swelling) behind the eye, and liver changes. Usually occurring in patients with weakened immune systems, progressive multifocal leukoencephalopathy (PML) is a rare but serious brain infection that could potentially occur. Along with some of the other long-term treatments for MS, PML has been reported in a small number of individuals taking Gilenya.

According to the FDA’s press release, Gilenya may also increase the risk of serious infections and patients should be monitored for infection during treatment and for two months after the discontinuation of their treatment. Other serious adverse events include an increased risk for swelling and narrowing of the blood vessels in the brain (posterior reversible encephalopathy syndrome), respiratory problems, liver injury, increased blood pressure, and skin cancer. Since this medication may cause harm to a developing fetus, women of child-bearing age should discuss with their doctor the use of effective contraception.

In May 2018, Gilenya became the first DMT also approved for the treatment of children and adolescents, ages 10 through 17, with relapsing forms of MS. At this time, Gilenya is the only DMT approved for this patient population, referred to as “pediatric MS.” However, the FDA states that this approval of the three generic applications is for relapsing forms of multiple sclerosis (MS) in adult patients, and does not specify if pediatric MS will be included within these medicines’ indications at this time.

The following quote was also included in the FDA’s press release: “Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA,” said Janet Woodcock, M.D., 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.”

The three pharmaceutical companies who received this approval of their generic Gilenya are HEC Pharm Co. Limited, Biocon Limited, and Sun Pharmaceutical Industries Limited. Further details on how soon these companies may market their generic versions of Gilenya and when these will be available to the MS community have not yet been announced. MSAA will update this information as soon as it becomes available.


For More Information

For general information or to speak with a trained Client Services Specialist, please call MSAA’s Helpline at (800) 532-7667, extension 154. Questions to MSAA’s Client Services department may also be emailed to MSquestions@mymsaa.org.

Written by Susan Wells Courtney, MSAA Senior Writer

Reviewed by Dr. Barry A. Hendin, MSAA Chief Medical Officer