The US Food and Drug Administration (FDA) has approved Eicos Sciences's Aurlumyn (iloprost) injection, a new treatment for adults with severe frostbite to lower the risk of amputation of fingers or toes.
Aurlumyn contains iloprost, a vasodilator that opens blood vessels and stops blood clotting, as its active ingredient.
The efficacy of iloprost in treating severe frostbite was established through an open-label controlled trial in 47 adult subjects.
Participants were randomised into three groups, with group one receiving iloprost intravenously for six hours daily for up to eight days along with aspirin and standard of care.
Groups two and three were administered other medications, with and without iloprost, which are not approved for frostbite treatment.
The trial’s primary efficacy measure was bone scans on day seven following the frostbite incident to predict the need for amputation.
The scans showed that none of the subjects who received iloprost alone (group one) required amputation compared to 19% in group two and 60% in group three.
This indicated a significant reduction in the presence of bone scan abnormalities in groups receiving iloprost.
Most subjects had follow-up data available to confirm whether they underwent amputation. This aligned with the bone scan findings.
Headache, flushing, heart palpitations, nausea and hypotension were common side effects linked to Aurlumyn treatment.
The treatment carries a warning for potential symptomatic hypotension.
Aurlumyn was granted priority review and orphan drug designations for this indication, highlighting its significance in addressing severe frostbite, a condition that can escalate from mild to severe, potentially leading to permanent tissue damage and the cessation of blood flow.
Iloprost originally received approval in 2004 for pulmonary arterial hypertension.
FDA Center for Drug Evaluation and Research Division of Cardiology and Nephrology director Norman Stockbridge stated: “This approval provides patients with the first-ever treatment option for severe frostbite.
“Having this new option provides physicians with a tool that will help prevent the life-changing amputation of one’s frostbitten fingers or toes.”
