Novartis is celebrating this morning after regulators in the USA gave the green light to its multiple sclerosis pill fingolimod beating Merck KGaA in the race to get to this key market first.
The US Food and Drug Administration has approved fingolimod, which will be marketed as Gilenya, as first-line treatment for relapsing MS, the most common forms of the disease. The thumbs-up comes as no surprise as the FDA's Peripheral and Central Nervous System Drugs Advisory Committee recommended approval in June, voting unanimously, 25 to 0, that fingolimod is safe and effective and 21 to 3 that the drug could be used as first-line treatment.
Gilenya is the first in a new class of drugs called sphingosine 1-phosphate receptor (S1PR) modulators. It is thought to work by retaining certain white blood cells in the lymph nodes, preventing from reaching the central nervous system, where they could potentially attack the protective covering around the nerve fibres.
The approval has gone down well with patient groups across the pond. Nicholas LaRocca at the National Multiple Sclerosis Society, said that "a new treatment option that offers significant efficacy in the convenience of a capsule is a welcome alternative to frequent injections". Novartis cited Fred Lublin, of the Corinne Goldsmith Dickinson Center for Multiple Sclerosis at Mount Sinai School of Medicine, as saying that "Gilenya provides significant efficacy and manageable safety when used in accordance with approved labelling".
The label states that heart rate will usually slow down the most about six hours after a patient takes their first dose of Gilenya, so doctors will watch patients for that time to see if they have any serious side effects - infections, macular oedema, breathing and liver problems. The approval comes with a risk evaluation and mitigation strategy and Novartis will initiate a five-year, worldwide post-marketing safety study.
Trevor Mundel, head of development at Novartis Pharma, said the firm is now actively pursuing regulatory approval in Europe and the rest of the world, having received the green light in Russia earlier this month.
Gilenya is set to become the leading treatment in MS "with multi-blockbuster sales, ending the decade long dominance of interferon betas and Teva's Copaxone (glatiramer acetate)", according to Trung Huynh, healthcare analyst at Datamonitor. He expects the drug to capture seven major market sales of $2.4 billion in 2019, adding that with the forthcoming arrivals of more oral and efficacious therapies driving, "these are exciting times ahead for the development and treatment of MS".
The FDA's decision means Novartis has stolen a march on nearest rival Merck KGaA whose MS pill Movectro (cladribine) is expected to be reviewed in the USA in the fourth quarter. The latter drug was resubmitted to the agency in June, seven months after receiving a 'refuse to file' letter from the FDA, and has been given a priority review.