FDA Approves First Generics of Novartis’ Blockbuster MS Drug

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The agency has approved three applications for generic versions of Gilenya (fingolimod), Novartis’ blockbuster multiple sclerosis drug.

FDA has approved three applications for first generics of Novartis’ Gilenya (fingolimod) capsules for treating relapsing forms of multiple sclerosis (MS) in adult patients, the agency announced on Dec. 5, 2019. FDA granted the generic approvals to HEC Pharm, a private pharmaceutical company in China, Biocon, a biopharmaceutical company based in India, and Sun Pharmaceutical Industries, a pharmaceutical company also based in India. Novartis’ Gilenya, first approved by FDA in September 2010, is a widely used orally administered treatment option for MS. The drug had over $3.3 billion in sales in 2018.

Fingolimod must be dispensed with a medication guide containing important information about its uses and risks, FDA stated in a press release. Serious risks include slowing of the heart rate, especially after the first dose. The drug may increase the risk of serious infections, and patients should be monitored for infection during treatment and for two months after discontinuation of treatment.

Other risks of taking the drug include the onset of progressive multifocal leukoencephalopathy (PML), a rare brain infection that usually leads to death or severe disability. PML has been reported in patients being treated with the drug and usually occurs in patients with weakened immune systems. Furthermore, fingolimod can cause vision problems, may increase the risk for swelling and narrowing of the blood vessels in the brain (posterior reversible encephalopathy syndrome), and can result in respiratory problems, liver injury, increased blood pressure, and skin cancer. FDA also cautions that the drug may cause harm to a developing fetus and warns health care professionals to advise women of child-bearing age that there is this potential risk and to use effective contraception.


“Approving safe and effective generics so patients have more treatment options continues to be a priority for [FDA],” said Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, in the agency’s press release. “Having access to affordable treatments is important for patients with conditions that require ongoing care. [FDA] has a longstanding commitment to increasing patient access to lower-cost, high-quality generic medicines.”

Source: FDA