Emicizumab looks like it’s headed toward approval in Europe for the prevention and reduction of bleeding episodes in patients with hemophilia A with factor VIII inhibitors.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended granting marketing authorization to the drug in January 2018, according to a statement. The recommendation will now be considered by the European Commission.
The Committee based its decision on results from two phase 3 clinical trials: a randomized study of 109 hemophilia A patients with inhibitors aged 12 years and older and an ongoing single-arm study of children under age 12 years. Overall, the prophylactic use of emicizumab reduced bleeding episodes requiring treatment by 80%-90%, compared with on-demand use of bypassing agents without prophylactic treatment.
Emicizumab, which is marketed in the United States as Hemlibra, was approved by the Food and Drug Administration for adult and pediatric patients with hemophilia A with Factor VIII inhibitors in November. It is the first monoclonal antibody to be recommended for use in patients with hemophilia A with inhibitors, says the statement.
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Emicizumab looks like it’s headed toward approval in Europe for the prevention and reduction of bleeding episodes in patients with hemophilia A with factor VIII inhibitors.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended granting marketing authorization to the drug in January 2018, according to a statement. The recommendation will now be considered by the European Commission.
The Committee based its decision on results from two phase 3 clinical trials: a randomized study of 109 hemophilia A patients with inhibitors aged 12 years and older and an ongoing single-arm study of children under age 12 years. Overall, the prophylactic use of emicizumab reduced bleeding episodes requiring treatment by 80%-90%, compared with on-demand use of bypassing agents without prophylactic treatment.
Emicizumab, which is marketed in the United States as Hemlibra, was approved by the Food and Drug Administration for adult and pediatric patients with hemophilia A with Factor VIII inhibitors in November. It is the first monoclonal antibody to be recommended for use in patients with hemophilia A with inhibitors, says the statement.
[email protected]
Emicizumab looks like it’s headed toward approval in Europe for the prevention and reduction of bleeding episodes in patients with hemophilia A with factor VIII inhibitors.
The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended granting marketing authorization to the drug in January 2018, according to a statement. The recommendation will now be considered by the European Commission.
The Committee based its decision on results from two phase 3 clinical trials: a randomized study of 109 hemophilia A patients with inhibitors aged 12 years and older and an ongoing single-arm study of children under age 12 years. Overall, the prophylactic use of emicizumab reduced bleeding episodes requiring treatment by 80%-90%, compared with on-demand use of bypassing agents without prophylactic treatment.
Emicizumab, which is marketed in the United States as Hemlibra, was approved by the Food and Drug Administration for adult and pediatric patients with hemophilia A with Factor VIII inhibitors in November. It is the first monoclonal antibody to be recommended for use in patients with hemophilia A with inhibitors, says the statement.
[email protected]
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