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The U.S. Food and Drug Administration (FDA) has approved HEMLIBRA® (emicizumab) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adults and children with hemophilia A with factor VIII inhibitors.
In a recent press release, Alnylam Pharmaceuticals announced that the company had achieved “alignment” with the U.S. Food and Drug Administration (FDA) on safety measures and risk mitigation strategies with an eye towards resuming clinical trials of the investigational therapy fitusiran. Alnylam is developing the therapy to treat patients with hemophilia A and B, both with and without inhibitors.
The history of hemophilia treatment is marked by an evolution that has ultimately led to increased life expectancy for persons with hemophilia. By 2050, 20% of the hemophilia population will be over 60 years of age. The increase in life expectancy among persons with hemophilia has been accompanied by the emergence of conditions related to aging in the hemophilia population.
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