FDA Approves First Injectable Treatment for Severe Frostbite

ArtShotPhoto / shutterstock.com
ArtShotPhoto / shutterstock.com

Major medical breakthroughs have been declining for the past few decades, but every once in a while, researchers still stumble upon something remarkable. That appears to have happened with a new drug called Aurlumyn. The drug has had a 100% success rate in preventing amputation among people with severe frostbite, and the FDA has just granted it approval.

Actelion Pharmaceutical originally developed Aurlumyn as a treatment for pulmonary arterial hypertension. The drug works as an anti-clotting agent and was first approved for hypertension back in 2004.

In a trial of Aurlumyn, doctors studied 47 adults who had developed severe frostbite, which typically leads to the necessary amputation of fingers or toes. All of the patients were given aspirin and standard care for frostbite.

One subgroup was given Aurlumyn through an IV for six hours per day, for eight days. A second subgroup received Aurlumyn and an unapproved medication. The third subgroup received only unapproved medications.

Among the group that received only Aurlumyn, doctors had a 100% success rate in preventing amputations. In the second group, 19% of patients lost fingers or toes. In the third group, more than 60% needed amputation.

“This approval provides patients with the first-ever treatment option for severe frostbite,” noted Dr. Norman Stockbridge at the FDA. “Having this new option provides physicians with a tool that will help prevent the lifechanging amputation of one’s frostbitten fingers or toes.”

Severe frostbite happens when the skin and tissue in extremities freeze, which stops the flow of blood to that body part (usually fingers or toes). The tissue eventually dies, leaving amputation the only available option. Aurlumyn can be injected directly into the frostbitten tissue to prevent blood clotting.

The new medication will be available starting in the spring of 2024, although pricing has not yet been set.