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Published 29 Mar, 2025 06:56am

US regulator approves bleeding disorder therapy

WASHINGTON: The US Food and Drug Administration (FDA) approved French drugmaker Sanofi’s haemophilia therapy, paving the way for a new type of treatment for patients with the rare blood clotting disorder, the regulator said on Friday.

Sanofi’s subcutaneous, or under-the-skin, therapy helps prevent bleeding and lowers antithrombin, a protein that delays blood clotting, for haemophilia patients aged 12 years and older. It is a first-in-class, antithrombin-lowering therapy for people with haemophilia A or B, with or without inhibitors.

The haemophilia market has been dominated by factor replacement therapies for decades. However, recently, gene therapies such as CSL’s Hemgenix and BioMarin Pharmaceutical’s Roctavian have been approved as an alternative in the United States.

Published in Dawn, March 29th, 2025

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