FDA Approves Three Generic Applications of Novartis' Gilenya (Fingolimod) for Adult Multiple Sclerosis Treatment

2019Year12Month5Day, VCBeat (WeChat ID:vcbeat) According to foreign media reports, Swiss pharmaceutical giant Novartis (Novartis) announced its generic drugGilenyaThree generic applications of (fingolimod) have been approvedFDAapproval, respectively granted toHEC Pharm Co. Limited、Biocon LimitedandSun Pharmaceutical Industries Limited. It is reported that the drug will be used for adult patients with multiple sclerosis (MS）。

It is reported that Gilenya was first approved by the FDA in 2010 for the treatment of adults with relapsing forms of multiple sclerosis. On May 11, 2019, the FDA approved Novartis’ Gilenya for the treatment of multiple sclerosis (MS) in children and adolescents aged 10 years and older, marking the first FDA approval of a drug for the treatment of pediatric MS.

Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research, stated, “Approving safe and effective generic drugs to provide patients with more treatment options remains a priority for the FDA. Affordable treatments are critical for patients requiring ongoing care; therefore, the FDA has long been committed to providing patients with low-cost, high-quality generic drugs.”

Multiple sclerosis (MS) is a central nervous system demyelinating disease that disrupts communication between the brain and other parts of the body. It is one of the most common causes of neurological disability among young people, with a higher incidence in women than in men. For most patients with MS, the initial course involves functional deterioration and the emergence of new symptoms, known as relapses or exacerbations, followed by periods of recovery. However, over time, recovery may be incomplete, potentially leading to progressive functional decline and increased disability. In this context, Gilenya, developed by Novartis, is a widely used oral therapy.

In the clinical trial reports for Gilenya, the most common side effects include headache, elevated liver enzymes, diarrhea, cough, influenza, sinusitis, back pain, abdominal pain, and pain in the extremities.

Gilenya must be dispensed with a Medication Guide containing important information about its use and risks. Serious risks include bradycardia, particularly after the first dose. Additionally, Gilenya may increase the risk of serious infections; therefore, patients should be monitored for infections during treatment and for two months after discontinuation.

Additionally, Gilenya may cause vision problems; it may increase the risk of swelling and narrowing of blood vessels in the brain (posterior reversible encephalopathy syndrome); the drug may also harm a developing fetus. Other serious risks include respiratory problems, liver damage, high blood pressure, and skin cancer.

(Compiled by Xiong Hui)