FDA approves Aurlumyn as first-ever treatment for severe frostbite

Key takeaways:

• Aurlumyn is the first medication to receive FDA approval for the treatment of severe frostbite.
• The approval was supported by a randomized, open-label study consisting of 47 patients.

Aurlumyn injection has been approved for the treatment of severe frostbite in adults to reduce the risk of finger or toe amputation, the FDA announced in a press release.

“This approval provides patients with the first-ever treatment option for severe frostbite,” Norman Stockbridge, MD, PhD, director of the division of cardiology and nephrology in the FDA’s Center for Drug Evaluation and Research, said in the release. “Having this new option provides physicians with a tool that will help prevent the life changing amputation of one’s frostbitten fingers or toes.”

Aurlumyn (iloprost, Eicos Sciences Inc.) received priority review and orphan drug designation in this indication. The medication contains the active ingredient iloprost, which was originally approved in 2004 for the treatment of pulmonary arterial hypertension and is a vasodilator, meaning it helps open the blood vessels to prevent blood clotting.

In the case of severe frostbite, which occurs when both the skin and underlying tissue are frozen causing blood to stop flowing and possibly resulting in amputation, iloprost helps prevent the cessation of blood flow.

The approval was supported by a randomized, open-label study where 47 adults with severe frostbite received aspirin intravenously as well as standard of care treatment and were assigned to one of three treatments groups.

In the first treatment group (n = 16), patients received Aurlumyn intravenously for 6 hours daily for up to 8 days. The second group (n = 16) received off-label treatment with iloprost, and the third group (n = 15) received off-label medication without iloprost.

Seven days after initial frostbite, bone scans found that none of the patients that received Aurlumyn required amputation. On the other hand, three (19%) patients in group two and nine (60%) in group 3 received bone scans that showed a predictive need for amputation.

According to the press release, common side effects of Aurlumyn may include headache, flushing, heart palpitations, fast heart rate, nausea, vomiting, dizziness and hypotension. The medication also received a warning and precaution for symptomatic hypotension.