U.S. FDA approves Roche’s bleeding disorder drug
Custom Synthesis, Roche said on Thursday it received approval from U.S. regulators for its hemophilia A drug Hemlibra for use in nearly all patients, as the Swiss drugmaker pushes deeper into diseases beyond cancer to replace revenue from older, patent-expired drugs.
Hemlibra was first approved in November for adults and children with hemophilia A with factor VIII inhibitors.
The injectible medicine that helps blood to clot in patients with the genetic disorder had previously been approved in the United States and Europe for those who had developed resistance, called inhibitors, to older treatments.
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