# 2025-00750: Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ALHEMO (concizumab-mtci)

2025-00750, Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ALHEMO (concizumab-mtci), is a Federal Register notice from an unnamed agency published 2025-01-15, effective 2024-12-20; PRIA reads it as touching household money (as of 2026-06-08).

- Canonical: https://policyrisk.com/federal-register/2025-00750
- As of: 2026-06-08
- Plain-text twin of the page above; the HTML and this file carry the same facts.

## Facts
- Document number: 2025-00750
- Title: Issuance of Priority Review Voucher; Rare Pediatric Disease Product; ALHEMO (concizumab-mtci)
- Type: Notice
- Agencies: unknown
- Citation: unknown
- Published: 2025-01-15
- Effective: 2024-12-20
- Comments close: not stated
- Significant: no
- Touches household money: yes
- Regulation identifier numbers: none
- Last updated: 2026-06-08

## Summary

The FDA just gave a special fast-track ticket called a Priority Review Voucher to Novo Nordisk for their new rare pediatric disease drug, ALHEMO, approved in December 2024. This voucher helps speed up the review of future medicines, benefiting patients with rare diseases and encouraging companies to develop more treatments. This move affects drug makers and could speed up new medicine approvals, saving time and possibly money.

## Abstract

The Food and Drug Administration (FDA) is announcing the issuance of a priority review voucher to the sponsor of a rare pediatric disease product application. The Federal Food, Drug, and Cosmetic Act (FD&C Act) authorizes FDA to award priority review vouchers to sponsors of approved rare pediatric disease product applications that meet certain criteria. FDA is required to publish notice of the award of the priority review voucher. FDA has determined that ALHEMO (concizumab-mtci), approved on December 20, 2024, manufactured by Novo Nordisk, Inc., meets the criteria for a priority review voucher.

## Effects PRIA read

- ALHEMO Approved for Hemophilia Prophylaxis: benefit, high. ALHEMO (concizumab-mtci) was approved on December 20, 2024 for routine prophylaxis to prevent or reduce bleeding episodes in adult and pediatric patients 12 years of age and older with hemophilia A with FVIII inhibitors and hemophilia B with FIX inhibitors. If you or a child in your care is in thos…
- Priority Review Voucher Issued to Sponsor: benefit, medium. The FDA issued a Priority Review Voucher under section 529 of the FD&C Act to the sponsor of the ALHEMO application (manufactured by Novo Nordisk, Inc.). The notice states ALHEMO met the criteria for a rare pediatric disease priority review voucher following its approval on December 20, 2024.

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## Sources
- [2025-00750 on federalregister.gov](https://www.federalregister.gov/documents/2025/01/15/2025-00750/issuance-of-priority-review-voucher-rare-pediatric-disease-product-alhemo-concizumab-mtci)
- [2025-00750 as published (PDF)](https://www.govinfo.gov/content/pkg/FR-2025-01-15/pdf/2025-00750.pdf)

## Related
- [Previous: 2025-00749, Qualification of Drivers; Exemption Applications; Implantable Cardioverter Defi…](https://policyrisk.com/federal-register/2025-00749)
- [Next: 2025-00752, Arts Advisory Panel Meetings](https://policyrisk.com/federal-register/2025-00752)
- [All Federal Register documents](https://policyrisk.com/federal-register)

Source: PRIA, https://policyrisk.com/federal-register/2025-00750 (as of 2026-06-08).