Roche's Hemlibra Wins Expanded FDA Approval, Opening The Door To Broad Hemophilia A Opportunity

An expanded indication for Roche's Hemlibra (emicizumab-kxwh) to prevent or reduce bleeding episodes in adults and children with hemophilia A without factor VIII inhibitors will significantly increase the commercial opportunity for the drug. The Swiss drug maker announced the FDA approval of Hemlibra for routine prophylaxis in the expanded population Oct. 4.

Hemlibra was originally approved in the US for hemophilia A in patients with factor VIII inhibitors in November 2017, but the initial approval was for a small subset of the market. Inhibitors are antibodies that develop when the immune system views infused clotting factor as a foreign substance to be attacked, before it has time to stop the bleeding