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# FDA Approves Eicos Frostbite Drug
- URL: https://www.fdaweb.com/fda-approves-eicos-frostbite-drug/
- Published: 2024-02-14T12:00:00.000Z
- Updated: 2026-09-14T14:23:02.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156359

FDA has approved an Eicos Sciences NDA for Aurlumyn (iloprost) injection to treat severe frostbite in adults to reduce the risk of finger or toe amputation. The drug’s efficacy was established in an open-label, controlled [trial](https://www.nejm.org/doi/full/10.1056/NEJMc1000538?ref=fdaweb.com) involving 47 adults with severe frostbite, according to an [FDA release](https://www.fda.gov/news-events/press-announcements/fda-approves-first-medication-treat-severe-frostbite?utm%5Fmedium=email&utm%5Fsource=govdelivery). Patients were divided into three groups. Group 1 received iloprost by vein (intravenously) for six hours daily for up to eight days. The two other groups received other medications that are unapproved for frostbite, given with iloprost (Group 2) or without iloprost (Group 3). The agency says that the primary efficacy measure was a bone scan taken seven days after initial frostbite that was used to predict the need for amputation.

“On day seven, the bone scan finding predictive of needing amputation was observed in 0% (0 of 16) patients receiving iloprost alone (Group 1) compared to 19% (3 of 16) patients in Group 2 and 60% (9 of 15) patients in Group 3,” FDA says. “The presence of the bone scan abnormality was significantly lower in the two groups receiving iloprost.”