Novartis is celebrating after getting the green light in Europe for its oral multiple sclerosis pill Gilenya.
Specifically, the European Commission has granted approval for Gilenya (fingolimod) as a disease modifying therapy in patients with highly active relapsing-remitting MS after treatment with beta interferon, or in patients whose disease is rapidly evolving. The thumbs-up comes as no surprise given that the European Medicines Agency's Committee for Medicinal Products for Human Use recommended approval two months ago.
The approval is more limited than that granted by the US Food and Drug Administration for Gilenya in September but a European green light pushes Novartis even further ahead in the oral MS market. Merck KGaA's rival pill Movectro (cladribine) was turned down by the FDA earlier this month, while a marketing application for the latter was withdrawn in Europe in February.
Novartis quoted Hans-Peter Hartung of the Heinrich-Heine University, Germany, as saying that the approval "marks an important step forward in the way we manage this chronic, debilitating disease in Europe". Gilenya "offers significant efficacy in a capsule, which for many patients will come as a welcome additional option,” he added.
Gilenya, which is licensed from Japan's Mitsubishi Tanabe Pharma Corp, is the first in a new class of drugs called sphingosine 1-phosphate receptor modulators. Analysts believe it is going to be an enormous seller, with some expecting annual revenues in the next few years of around $5 billion.