Posted from: Friday, December 01, 2017 - 12:49 PM - Present

Hemlibra Approved for Hemophilia A

November 16, 2017 – The U.S. FDA has approved Hemlibra® (emicizumab-kxwh), manufactured by Genentech, to provide routine prophylaxis for the prevention or reduction of frequency of bleeding episodes in adult and pediatric patients with hemophilia A who have developed factor VIII inhibitors. Factor VIII inhibitors are a type of antibody that work against factor VIII replacement therapies used to treat patients who have hemophilia A. The presence of these antibodies leads to an increased risk of bleeds caused by the disease, which can be life-threatening.

A chronic genetic disorder, hemophilia A is a rare condition that affects an estimated 16,000 people in the United States. It results in insufficient production of clotting factor VIII. This leads to bleeding episodes that can cause joint damage, pain, and life-threatening hemorrhages. Approximately one-third of patients diagnosed with severe hemophilia A develop factor VIII inhibitors.

A bispecific monoclonal antibody, Hemlibra works by adhering to activated coagulation factor IXa and factor X to prevent and reduce bleeding episodes. This works in place of coagulation factor VIII in patients who have factor VIII inhibitors.

Recommended dosing for Hemlibra is 30mg/kg, delivered subcutaneously once per week for the first four weeks of treatment. Thereafter, dosing should be 1.5mg/kg once per week. Hemlibra carries a black box warning that cautions it may contribute to severe blood clots (thrombotic microangiopathy and thromboembolism) when administered to patients who have also been given activated prothrombin complex concentrate, a rescue treatment for bleeding.

Hemlibra has already been launched.


Adverse reactions or quality problems experienced with the use of a recalled product may be reported to the FDA’s MedWatch Adverse Event Reporting Program either online, by U.S. mail or by fax.

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Last Updated Friday, September 20, 2019 - 07:16 PM.