On Feb. 14, the FDA approved Aurlumyn, the nation's first treatment for severe frostbite.
Severe frostbite, which is estimated to affect 1% of the general population, happens when the skin and underlying tissue are frozen and blood flow is stopped. Aurlumyn (iloprost) is an injection that works by opening blood vessels, preventing blood from clotting.
The skin damage from severe frostbite sometimes requires finger and toe amputations. In a trial of 47 patients, a bone scan after one week predicted that zero of the 16 study participants who received iloprost alone would need an amputation, compared to 3 of the 16 who received the drug with another experimental frostbite therapy and 9 of 15 who received another unapproved therapy alone.
Actelion Pharmaceuticals US received the drug approval.