FDA Approves First Generics for Common Multiple Sclerosis Drug


Fingolimod treats relapsing forms of multiple sclerosis in adult patients.

The FDA has approved 3 applications for generics of fingolimod (Gilenya, Novartis). These are the first generics of the drug, which treats relapsing forms of multiple sclerosis (MS) in adult patients.1

The approvals were granted to HEC PharmD Co. Limited, Biocon Limited, and Sun Pharmaceutical Industries Limited.1

MS is a chronic, inflammatory autoimmune disease that disrupts communication between the brain and other parts of the body.1 It is one of the most common causes of neurological disability in young adults.1

According to the National Multiple Sclerosis Society, the disease is believed to affect nearly 1 million adults in the United States. Most people are diagnosed between the ages of 20 and 50 years, and it is 2 to 3 times more common in women than men.2

For most people with MS, relapses are initially followed by remissions; however, over time recovery may be incomplete, leading to progressive decline in function and increased disability. Fingolimod capsules are a commonly used, orally administered treatment option.1

The most common adverse effects reported in clinical trials for fingolimod are headache, elevation of liver enzymes, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in the extremities.1 Serious risks include slowing of the heart rate, especially following the first dose.1


  • FDA approves first generics of Gilenya [news release]. White Oak, Maryland; released Dec 5, 2019: FDA website. https://www.fda.gov/news-events/press-announcements/fda-approves-first-generics-gilenya. Accessed Dec 5, 2019.
  • Who Gets MS? National Multiple Sclerosis Society. https://www.nationalmssociety.org/What-is-MS/Who-Gets-MS. Accessed Dec 5, 2019.

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