Drug Info

FDA approves Gilenya generic

Avatar By | December 10, 2019
Medically reviewed by Karen Berger, Pharm.D.

For nearly a decade, people with relapsing cases of multiple sclerosis (MS) had basically one treatment option: Gilenya. It was the only FDA-approved medication for adults and children age 10 and older, until last week.

On December 5, the U.S. Food and Drug Administration (FDA) announced approval for generic Gilenya, fingolimod, to HEC Pharm Co. Limited, Biocon Limited, and Sun Pharmaceutical Industries Limited. 

What is Gilenya?

Manufactured by Novartis Pharmaceuticals Corporation, Gilenya was first approved by the FDA in 2010. It was the first oral treatment created for reducing relapses and slowing disease progression. In 2018, the FDA expanded its approval for the drug to include pediatric patients. 

The currently recommended dosage of Gilenya for adults and children who are 10 years or older and weigh at least 40 kg is one 0.5 mg capsule per day. Children who are at least 10 years old but weigh 40 kg or less should take one 0.25 mg capsule per day.

What is MS?

MS is an autoimmune inflammatory disease, meaning the body’s immune cells attack the fatty covering of nerve fibers, disrupting nerve impulses and causing symptoms like muscle weakness, fatigue, numbness or tingling, muscle spasms, difficulty walking, vision changes, and even bladder or bowel dysfunction. Many people experience cycles of relapses followed by remissions. Over time, it’s harder to achieve complete remission after a flare-up, and the disease progresses.

Gilenya is the most commonly used treatment in these cases. It is thought to work by reducing the immune cells circulating in the body, thereby reducing the attacks on nerve cells that cause symptoms.

How much does Gilenya cost?

Partially because of patent protections, the cost of Gilenya remained high—an average price of $8,211 for a 30-day supply of 0.5mg capsules. Though, Novartis says that most health insurance plans cover the medication, including 99% of people with commercial insurance and 96% of people with Medicaid or Medicare. Novartis also offers two co-pay support programs to assist with payment for the drug.

These approvals are the first step toward generic competition, which could lower costs of this treatment.

“Addressing the challenges related to developing generics and promoting more generic competition is a key part of the FDA’s Drug Competition Action Plan and the agency’s efforts to help increase patient access to more affordable medications,” the FDA statement said.

When will generic Gilenya be available?

It has not yet been announced when the three pharmaceutical manufacturers who received approval will begin selling the fingolimod (Gilenya generic) in the United States. No pricing structure is available yet, either.