First Generics Approved for MS Drug Gilenya

December 6, 2019 – The U.S. FDA has approved the first generics for Novartis’s Gilenya® (fingolimod), which is approved to treat relapsing forms of multiple sclerosis (MS) – including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease – in patients who are at least 10 years of age.

Multiple sclerosis is a disease of the central nervous system (CNS) that occurs when the body’s immune system attacks the protective sheaths (myelin) that cover nerve fibers (axons). In order for these attacks to occur, the immune system must cross the blood-brain barrier that protects the CNS. Gilenya’s active pharmaceutical ingredient, fingolimod, is believed to fight MS by keeping one type of immune cell called lymphocytes confined within the lymph nodes. This prevents the cells from moving into the central nervous system to destroy myelin.

First FDA approved in 2010, fingolimod has a recommended dose of 0.5mg taken by mouth once daily for adults and for pediatric patients who weigh more than 40kg (88 pounds). For pediatric patients who weigh 40kg or less, the recommended dose is 0.25mg taken by mouth once daily.

Initiating fingolimod causes a decrease in heart rate, so patients must have an electrocardiogram (ECG) done before starting treatment with the drug and undergo first-dose monitoring. The first dose of fingolimod must be given in a setting with appropriate resources for managing bradycardia (slow heart rate). Patients should be monitored for at least six hours after the first dose, with their pulse and blood pressure checked hourly. Further monitoring may be required depending on the patient’s response. If treatment with fingolimod is interrupted, first-dose monitoring may be required again when the treatment is reinitiated.

Three manufacturers have received FDA approval for their generics – Biocon, HEC Pharm, and Sun Pharmaceuticals. However, they are not yet able to launch their products. Novartis’s patent for Gilenya currently remains in effect until 2027.