Eicos Sciences’ Aurlumyn: First FDA-Approved Treatment for Severe Frostbite Reduces Amputation Risk

The U.S. Food and Drug Administration (FDA) has granted approval to Eicos Sciences' Aurlumyn (iloprost) injection for treating severe frostbite in adults, thereby reducing the risk of finger and toe amputations. This is the first medication approved for this purpose, marking a breakthrough in alleviating the impact of severe frostbite.

Aurlumyn, an iloprost-based drug, functions as a vasodilator, widening blood vessels to improve blood flow. It was initially approved in 2004 for pulmonary arterial hypertension. Eicos Sciences has been developing Aurlumyn specifically for frostbite treatment since the company's inception in 2017.

Key points from the FDA's approval include:

- Iloprost, the active ingredient, is a vasodilator that opens blood vessels and prevents blood clotting.
- A clinical trial involving 47 adults with severe frostbite demonstrated that none of the patients receiving iloprost alone needed amputation compared to 19% and 60% in other groups, as indicated by bone scan results.
- Aurlumyn is intended to aid physicians in preventing the life-changing amputation of frostbitten fingers or toes.
- The most common side effects include headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness, hypotension, and a warning for symptomatic hypotension.
- Aurlumyn has received Priority Review and Orphan Drug designations for its indication.

Aurlumyn is a significant breakthrough for patients and healthcare providers dealing with the treatment and management of severe frostbite, offering the first-ever approved treatment for this health concern. Aurlumyn is expected to be available in spring 2024.