Federal Register #FDA-2025-E-0158

FDA Regulatory Review Period Determination for HYMPAVZI (marstacimab-hncq) Patent Extension

This notice announces the FDA's determination of the regulatory review period for HYMPAVZI (marstacimab-hncq), a biologic drug for hemophilia, as part of the patent extension process. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEM Highlight: - Pfizer Inc. is the manufacturer of HYMPAVZI (marstacimab-hncq) - Product Details: - HYMPAVZI (marstacimab-hncq), a human biological product - Indicated for routine prophylaxis to prevent or reduce bleeding episodes in adults and children with hemophilia A or B without inhibitors - Patent No. 10,550,200 is the subject of the extension application - Regulatory Review Period: - Total review period determined: 2,858 days (includes both testing and approval phases) - Notable Requirements: - Notice invites public comments or petitions regarding the review period determination - No procurement or contract award is associated with this notice; it is strictly a regulatory action related to patent extension

Description

The Food and Drug Administration (FDA) has determined the regulatory review period for the human biological product HYMPAVZI (marstacimab-hncq) as part of the patent extension process. HYMPAVZI is indicated for routine prophylaxis to prevent or reduce bleeding episodes in patients with hemophilia A or B without inhibitors. The FDA's determination includes the testing and approval phases of the regulatory review period, which total 2,858 days. Interested parties may submit comments or petitions regarding the dates or the review process by specified deadlines.

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