The effectiveness of iloprost in treating severe frostbite was determined by an open-label, controlled trial in which none of the patients receiving iloprost alone required amputation
FDA clears Aurlumyn for severe frostbite treatment. (Credit: Simon Bauwens on Unsplash)
The US Food and Drug Administration (FDA) has authorised Eicos Sciences’ Aurlumyn (iloprost) injection to treat severe frostbite in adults to lower the risk of amputation of fingers or toes.
Iloprost is the active ingredient in Aurlumyn. It is a vasodilator that opens blood vessels and stops blood from clotting.
Previously, Aurlumyn secured Priority Review and Orphan Drug Designations for this indication from the US FDA.
Iloprost was initially approved in 2004 to treat pulmonary arterial hypertension.
The effectiveness of iloprost in treating severe frostbite was determined by an open-label, controlled trial of 47 people with severe frostbite.
The participants were randomly assigned to one of three treatment groups to receive aspirin via vein and routine care.
Group 1 was administered with iloprost intravenously for six hours daily up to eight days.
The other two groups were administered alternative drugs that are not authorised for treating frostbite, either with or without iloprost.
A bone scan that was taken seven days after the first frostbite was utilised as the main indicator of effectiveness. It was used to predict the amputation need.
The scan results showed that none of the patients receiving iloprost alone (Group 1) required amputation compared to 19% in Group 2 and 60% of patients in Group 3.
The presence of bone scan abnormalities was significantly lower in the two groups receiving iloprost.
Most patients had follow-up information on whether they subsequently underwent at least one finger or toe amputation. The results of the bone scan were consistent with the requirement for an amputation.
The treatment will be commercialised under the brand name Aurlumyn and is anticipated to be available in Spring 2024.