FDA Approves First Generic Forms of MS Drug Gilenya

FDA Approves First Generic Forms of MS Drug Gilenya

The first generic versions of the multiple sclerosis drug Gilenya have been approved by the U.S. Food and Drug Administration.

The three generic versions of Gilenya (fingolimod) capsules were approved for the treatment of relapsing forms of multiple sclerosis (MS) in adults.

"Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA," Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, said in an agency news release. "Having access to affordable treatments is important for patients with conditions that require ongoing care."

Many MS patients have periods of worsening function and the onset of new symptoms (relapses) that are initially followed by periods of recovery (remissions). But, over time, recovery may be incomplete, resulting in increased disability. Gilenya is a widely used treatment in such cases.

In clinical trials for Gilenya, the most common side effects were headache, the elevation of liver enzymes, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain and pain in the extremities, according to the FDA.

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

Fingolimod has a number of serious risks, including slowing of the heart rate, increased risk of serious infections, respiratory problems, liver damage, skin cancer, and increased blood pressure.

The drug may harm a developing fetus, so health care providers should warn female MS patients of childbearing age about that risk and advise them to use contraception, the FDA said.

MS is an inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and the rest of the body. It is one of the most common causes of neurological disability in young adults and occurs more often in women than in men.

Source: U.S. Food and Drug Administration, news release, Dec. 5, 2019.

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