FDA approves first generics for common multiple sclerosis drug

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
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.
2. Who Gets MS? National Multiple Sclerosis Society. https://www.nationalmssociety.org/What-is-MS/Who-Gets-MS. Accessed Dec 5, 2019.

By Aislinn Antrim, Assistant Editor

Pharmacy Times

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The industry news information and articles are for informational purposes only, and are not intended to represent any trends, partnerships, commitments, or research of the Consortium of MS Centers or any of it's members in any way whatsoever, nor should any party be libel in any way to the reader or to any other person, firm or corporation reading this industry news section. Although the CMSC site includes links providing direct access to other Internet sites, CMSC takes no responsibility for the content or information contained on those other sites, and does not exert any editorial or other control over those other sites. CMSC is providing information and services on the Internet as a benefit and service in furtherance of CMSC's nonprofit and tax-exempt status. CMSC makes no representations about the suitability of this information and these services for any purpose.

Elizabeth Porco

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