FDA Approves Pfizer’s Hympavzi for Hemophilia A, B

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The FDA has approved Hympavzi as a prophylactic treatment for hemophilia A and B patients to prevent or reduce bleeding episodes. This subcutaneous injection targets the anticoagulation protein TFPI, increasing the amount of pro-clotting enzyme thrombin in circulation. The approval was based on the BASIS trial, showing a significant reduction in bleeding episodes with Hympavzi. Common side effects include injection-site reactions, headaches, and itching. Pfizer now has two approved hemophilia treatments, with results for patients with clotting factor inhibitors expected in 2025. Hympavzi is the first non-factor, once-weekly treatment for hemophilia B in the US, while emicizumab is available for hemophilia A.

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