FDA Approves First Generics for Common Multiple Sclerosis Drug

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

REFERENCE

• 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.