Denmark-based Novo Nordisk snagged approval from the U.S. FDA for a new treatment for hemophilia A, though Esperoct will not be available in the United States until 2020.
Roche’s Hemlibra provided sustained bleed control in the largest pivotal study to date of children with a form of hemophilia, the Swiss drugmaker said.
U.S. regulators approved expanded use of Roche’s drug Hemlibra to include almost all patients with hemophilia A.
Swiss drugmaker Roche is breaking into hemophilia A treatment, a $10 billion global market dominated by rivals who have cultivated close ties to sufferers of the genetic bleeding disorder.
Bayer AG’s long-acting treatment for hemophilia A won a recommendation from a European Medicines Agency (EMA) panel for the treatment of the rare genetic disorder in which blood does not clot easily.
The U.S. regulatory agency approved Genentech’s Gazyva for patients with previously untreated advanced follicular lymphoma.
Bayer and Johnson & Johnson’s blockbuster clot prevention drug Xarelto was shown to cut the risk of potentially deadly strokes and heart attacks in patients with severe atherosclerosis by 24 percent, raising the prospects of billions more in sales.
Swiss pharma group Roche said the U.S. Food and Drug Administration granted priority review to its emicizumab for hemophilia A with inhibitors.
FDA accepted for Priority Review an sNDA for Xarelto for a 10 mg once-daily dose for reducing the risk of VTE after at least six months of standard anticoagulant therapy.