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First drug therapy for frostbite has been cleared by FDA

February 15, 2024


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.

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