The Food and Drug Administration on Thursday approved Genentech's hemophilia drug Hemlibra.
Hemlibra is a once-weekly injection for patients with hemophilia A who have developed a resistance to other treatments.
The drug's label contains a black box warning over the risk of severe blood clots in patients who receive a rescue treatment for breakthrough bleeds while taking Hemlibra.
"Today's approval of Hemlibra represents an important advancement for people with hemophilia A with inhibitors, who have struggled to manage their bleeding disorder and haven’t had a new medicine in nearly 20 years," said Sandra Horning, MD, chief medical officer and head of global product development for Genentech.