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US regulator approves bleeding disorder therapy

2025-03-29
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.-AFP