Roche has won FDA approval for its hemophilia A therapy, emicizumab, which will be marketed as Hemlibra.
The once-weekly injection for adults and pediatric patients with hemophilia A who have developed resistance to other treatments will come with a black box warning about the risk of blood clots.
Analysts polled by Reuters predict that Hemlibra will produce about $1.6 billion in annual sales by 2022.
The approval follows months of legal battles with rival Shire, with Shire alleging that Roche released misleading statements about the drug and under-reported adverse events in a Phase 3 trial.
