GILENYA is a sphingosine 1-phosphate receptor modulator indicated for the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in patients 10 years of age and older.
MS is a progressive chronic inflammatory and neurodegenerative disease of the central nervous system (brain and spinal cord) that can drastically affect an individual's everyday life and requires life-long treatment. The disease has a wide range of symptoms, beginning with blurred vision, fatigue, weak limbs, unsteadiness, and tingling sensations and leading to limited mobility and neurological decline.
Commenting on the launch, Sanjeev Krishan, President, Glenmark North America said, "We are very pleased to bring to market a lower cost alternative to Gilenya Capsules, 0.5 mg. This launch confirms our commitment to provide quality and affordable pharmaceutical products to patients."
According to IQVIA sales data for the 12-month period ending September 2022, the Gilenya Capsules, 0.5 mg market achieved annual sales of approximately $1.8 billion.
Glenmark's current portfolio consists of 176 products authorized for distribution in the U.S. marketplace and 47 ANDA's pending approval with the U.S. FDA.
Glenmark Pharmaceuticals Limited is a global research-led pharmaceutical company with a presence across generics, specialty and OTC businesses and with operations in over 50 countries. Glenmark's key therapy focus areas globally are respiratory, dermatology, and oncology.
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