First drug therapy for frostbite has been cleared by FDA

pharmaphorum February 15, 2024
Phil Taylor

People at risk of losing a finger or toe to frostbite now have the first FDA-approved treatment that could prevent a life-changing amputation.

The US regulator has cleared Aurlumyn (iloprost) injection from CiVi Biopharma subsidiary Eicos Sciences as a treatment for severe frostbite, caused by prolonged exposure to extreme cold, after a priority review.

The incidence of severe frostbite injury in the US is estimated at 0.8 out of 100,000 people, meaning that there are approximately 2,800 cases a year, with cases disproportionately affecting the homeless in urban areas, but also seen in military personnel, industrial workers, and people who engage in outdoor sports like mountaineering, skiing, and hiking.

There are thought to be around 14,000 cases of frostbite overall...

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