In a significant breakthrough, the American Food and Drug Administration (FDA) has greenlit the first-ever treatment to prevent limb amputation resulting from severe frostbite. Developed by Eicos Sciences, the intravenous drug named Aurlumyn has shown remarkable success in reducing the risk of amputations in clinical trials compared to standard care.
Frostbite, a cold-induced injury where skin and tissues freeze, poses serious risks. While mild cases might not result in permanent damage, prolonged exposure to the cold can cause blood vessels to constrict and ice crystals to form, potentially leading to severe consequences. Thawing after rescue can further harm the body, sometimes necessitating amputation due to permanent nerve damage or extensive tissue loss.
Until now, there were no established interventions to prevent limb amputation once severe frostbite was suspected. Patients typically received anti-inflammatory drugs post-rescue, and the outcome remained uncertain. However, Eicos Sciences’ Aurlumyn, containing iloprost, has changed the landscape.
Iloprost, a vasodilator previously approved for pulmonary hypertension, demonstrated promise in preventing amputations in earlier off-label studies. Eicos Sciences pursued formal FDA approval for its iloprost-based treatment after successful clinical trials.
The drug’s mechanism involves opening up blood vessels and preventing clots that could cause irreversible damage. Administered for several hours a day over a week, Aurlumyn significantly reduced the risk of amputation in a trial of 47 adults compared to standard care alone.
Norman Stockbridge, Director of the Division of Cardiology and Nephrology at the FDA, emphasized the historical significance of this approval, providing patients with the first-ever treatment for severe frostbite. While severe frostbite cases are rare, the availability of this treatment is crucial for populations consistently exposed to extreme cold, such as mountain climbers, military personnel, and homeless individuals.
