FDA Okays First Generics for MS Drug Fingolimod (Gilenya)

FDA Okays First Generics for MS Drug Fingolimod (Gilenya)

The US Food and Drug Administration (FDA) has approved three applications for first generic versions of fingolimod capsules (Gilenya, Novartis) for the treatment of adults with relapsing forms of multiple sclerosis (MS).

The FDA gave the green light to market generic versions of fingolimod to HEC Pharm Co Ltd, Biocon Ltd, and Sun Pharmaceutical Industries Ltd.

“Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, said in an agency statement.

“Having access to affordable treatments is important for patients with conditions that require ongoing care. The FDA has a long-standing commitment to increasing patient access to lower-cost, high-quality generic medicines,” said Woodcock.

MS is among the most common causes of neurologic disability in young adults.

Fingolimod, which was the first oral disease-modifying MS therapy, was approved by the FDA in September 2010 following a unanimous endorsement from the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee in June of that year.

Last year, the FDA expanded approval for fingolimod to the treatment of children and adolescents with relapsing MS who are aged 10 years or older.

Fingolimod acts as a superagonist to sphingosine-1-phosphate receptors on the surface of thymocytes and lymphocytes, reducing the overall number of circulating lymphocytes available to mount an autoimmune reaction to the myelin sheath surrounding axons in patients with MS.

The most common side effects reported in clinical trials include headache, elevation of liver enzyme levels, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in the extremities.

The FDA reminds providers that, as with brand name fingolimod, generic versions must be dispensed with a medication guide that describes important information about the drug’s uses and risks. Serious risks include slowing of the heart rate, especially after the first dose.

Fingolimod may increase the risk for serious infections, the FDA notes. Patients should be monitored for infection during treatment and for 2 months after discontinuation of treatment. Progressive multifocal leukoencephalopathy (PML) has been reported in patients being treated with the drug. PML cases usually occur in patients with weakened immune systems.

Fingolimod can cause vision problems and may increase the risk for swelling and narrowing of the blood vessels in the brain (posterior reversible encephalopathy syndrome). Other serious risks include respiratory problems, liver injury, increased blood pressure, and skin cancer. Fingolimod may cause harm to a developing fetus. Women of childbearing age should be advised of the potential risk to the fetus and to use effective contraception, the FDA said.

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