FDA Approves Alhemo for Patients with Hemophilia

Routine prophylaxis to prevent or reduce bleeding

For Patients with Hemophilia A or B with Inhibitors

The FDA has approved Alhemo (concizumab-mtci) for routine prophylaxis to prevent or reduce bleeding episodes in patients aged 12 and older with:

  • Hemophilia A with factor VIII inhibitors, or
  • Hemophilia B with factor IX inhibitors.

What It Is

  • Alhemo is a subcutaneous (under the skin) injection, taken daily.
  • It’s designed for patients who have developed inhibitors — antibodies that block standard clotting factor treatments.

Effectiveness

  • In a global phase 3 trial, Alhemo reduced annual bleeding rates by 86% compared to no prophylaxis.
  • Participants included 91 adults and 42 adolescents with hemophilia A or B, with inhibitors.

Safety Info

  • Most common side effects: Injection site reactions and hives.
  • May cause hypersensitivity (rash, itching, abdominal pain) and increased risk of blood clots.
  • Not recommended for patients with serious allergies to the drug or its ingredients.

Special FDA Designations

  • Priority Review
  • Orphan Drug status (for rare conditions)

Alhemo offers a new preventative option for a high-risk hemophilia population where standard clotting therapies may fail.

More novel drug approvals.

Editor’s Note: This is another in our series of potentially game-changing novel pharmaceuticals that FDA approved in 2024 and 2025. This approval report does not in any way recommend or promote this product. For more information contact your oncologist or the manufacturer. Report any adverse effects experienced with this product to FDA’s Medwatch System.

More approved novel drugs

FDA Alhemo Approval Notice

News

FDA Enforcement

Safety Alerts

Medical Devices

Pharma

New Drugs

Drug Shortages

Fresenius Kabi Recalls Ivenix Infusion Pump Software 

Urgent Class I Recall Notice   A crucial recall notice has been issued by Fresenius Kabi USA, LLC for the LVP Software of the Ivenix Infusion System (IIS), Version 5.8.0, distributed between March 6, 2023, and March 20, 2024. The recall, initiated on March 7, 2024, is...

FDA – Do Not Use Non-piercing Devices to Measure Blood Glucose

FDA Safety Communication   On February 21, 2024 the U.S. Food and Drug Administration (FDA) issued a safety communication regarding the use of smartwatches or smart rings that claim to measure blood glucose levels without the need for skin piercing.   Its cautionary...

Medos International Recalls CEREBASE DA Guide Sheath 

Urgent Class I Recall Notice   Medos International Sàrl has issued an urgent recall for the Cerenovus CEREBASE DA Guide Sheath, a neurovascular catheter commonly used in procedures requiring precise navigation and access to blood vessels in the brain. The recall was...