April 23, 2024

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FDA Approves First Drug for Severe Frostbite: Aurlumyn, Expected to Launch in Spring 2024

FDA Approves First Drug for Severe Frostbite: Aurlumyn, Expected to Launch in Spring 2024



FDA Approves First Drug for Severe Frostbite: Aurlumyn, Expected to Launch in Spring 2024

The first drug to treat severe frostbite globally has been approved and is expected to be on the market this spring.

The Food and Drug Administration (FDA) recently announced the approval of the Aurlumyn injection developed by Eicos Sciences for the treatment of severe frostbite in adults, to reduce the risk of amputation of fingers or toes. Aurlumyn is reportedly the world’s first approved drug for the treatment of severe frostbite.

 

FDA Approves First Drug for Severe Frostbite: Aurlumyn, Expected to Launch in Spring 2024

 

Eicos Sciences stated in a release that this treatment method will help reduce the risk of amputation and will be sold under the Aurlumyn brand, expected to be on the market in spring 2024, although the selling price has not yet been determined.

Frostbite is a localized or systemic injury to the human body caused by exposure to cold and moisture. Frostbite can be divided into several stages, from mild frostbite that does not require medical intervention and does not cause permanent skin damage, to severe frostbite where the skin and underlying tissue freeze and blood flow stops, sometimes requiring amputation.

The active ingredient in Aurlumyn, iloprost, is a vasodilator that can prevent blood clotting. It was initially approved in 2004 for the treatment of pulmonary arterial hypertension.

The effectiveness of iloprost was mainly determined in a controlled trial. Forty-seven severely frostbitten adults were randomly assigned to three treatment groups. Group 1 received iloprost by intravenous infusion for 6 hours a day, for 8 days.

The other two groups received other unapproved frostbite drugs, with iloprost (group 2) or without iloprost (group 3). On day 7, bone scans predicted that no one in the group treated with iloprost alone would require amputation, while 3 out of 16 in group 2 and 9 out of 15 in group 3 needed amputation.

Dr. Norman Stockbridge, Director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research, said, “This approval provides the first treatment option for severe frostbite patients. With this new option, doctors have a tool to help those who need amputation due to frostbite.”

The most common side effects of Aurlumyn include headache, flushing, palpitations, increased heart rate, nausea, vomiting, dizziness, and low blood pressure.

Therefore, while the approval of Aurlumyn brings a new treatment option for patients, more research is needed to better understand its long-term effects and other potential effects. Nonetheless, the approval of Aurlumyn remains an important milestone in the field of medicine.

FDA Approves First Drug for Severe Frostbite: Aurlumyn, Expected to Launch in Spring 2024

(source:internet, reference only)


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