{"id":13971,"date":"2024-11-21T16:13:48","date_gmt":"2024-11-21T08:13:48","guid":{"rendered":"https:\/\/flcube.com\/?p=13971"},"modified":"2024-11-21T16:13:51","modified_gmt":"2024-11-21T08:13:51","slug":"pfizers-hympavzi-receives-european-commission-approval-for-hemophilia-a-and-b","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=13971","title":{"rendered":"Pfizer’s Hympavzi Receives European Commission Approval for Hemophilia A and B"},"content":{"rendered":"\n

US pharmaceutical major Pfizer Inc. (NYSE: PFE<\/a>) has announced that the European Commission (EC) has granted approval for its drug Hympavzi (marstacimab-hncq) for the routine prophylaxis of bleeding episodes in patients aged 12 years and older weighing at least 35 kg with severe hemophilia A (congenital factor VIII [FVIII] deficiency, FVIII <1%) without FVIII inhibitors or severe hemophilia B (congenital factor IX [FIX] deficiency, FIX <1%) without FIX inhibitors. This marks the first and only anti-tissue factor pathway inhibitor (anti-TFPI) approved in the European Union (EU) for the treatment of hemophilia A or B, and it is also the first hemophilia medicine approved in the EU to be administered via a pre-filled, auto-injector pen.<\/p>\n\n\n\n

Supporting Data from the Phase III BASIS Study<\/strong>
The approval is supported by data from the pivotal Phase III BASIS study, which involved the treatment of 116 eligible severe hemophilia patients with Hympavzi during a 12-month active treatment period (ATP). The study demonstrated that the drug significantly reduced the annualized bleeding rate (ABR) for treated bleeds by 35% (ABR of 5.08 vs. 7.85, p-value 0.0376) during the 12-month ATP. In the 16-month follow-up period of the long-term extension study, Hympavzi consistently reduced the average ABR by 2.79 (95% CI 1.90-4.09), showing non-inferiority compared to routine prophylaxis (RP) in all secondary endpoints related to bleeding, including spontaneous bleeding, joint bleeding, target joint bleeding, and total bleeding.<\/p>\n\n\n\n

Hympavzi’s Mechanism of Action and US Fast-Track Status<\/strong>
Hympavzi is a rebalancing agent that targets the Kunitz 2 domain of tissue factor pathway inhibitor (TFPI), making it a potential treatment for both hemophilia A and B patients. The drug was previously awarded fast-track status in the US, highlighting its potential significance in improving the standard of care for hemophilia patients.-Fineline Info & Tech<\/a><\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

US pharmaceutical major Pfizer Inc. 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