Eicos Sciences on Wednesday secured the FDA’s approval for its vasodilator iloprost, now to carry the brand name Aurlumyn, for the treatment of severe frostbite and to decrease the risk of amputation.
Norman Stockbridge, director of the Division of Cardiology and Nephrology at the FDA’s Center for Drugs and Evaluation Research, in a statement said Aurlumyn is the “first-ever treatment option for severe frostbite.”
“Having this new option provides physicians with a tool that will help prevent the lifechanging amputation of one’s frostbitten fingers or toes,” Stockbridge said.
Iloprost is a vasodilator whose mode of action is to loosen up blood vessels and prevent clots from forming. The drug was originally approved in 2004 in an inhalable form called Ventavis, manufactured by CoTherix and indicated for pulmonary arterial hypertension. In frostbites, vasodilation could help counter frozen tissues and keep blood flowing to the extremities, preventing amputation.
The FDA had previously given iloprost its Priority Review and Orphan Drug designation for severe frostbite.
Wednesday’s approval is backed by data from an open-label and controlled study that enrolled 47 severely frostbitten adults who were treated with intravenous aspirin plus standard of care. Patients were randomly assigned to receive Aurlumyn intravenously for six hours a day for up to eight days. The two other groups received unapproved frostbite interventions with or without Aurlumyn.
Treatment efficacy was measured using a bone scan, which was highly predictive of the risk of amputation.
The results, published in January 2011 in a correspondence article in The New England Journal of Medicine, demonstrated that patients treated with Aurlumyn alone saw a 0% risk of amputation, whereas those who did not receive Eicos’ vasodilator had a 60% likelihood of amputation. Patients who received Aurlumyn plus another unapproved therapy showed a 19% risk of amputation.
This risk reduction was validated by the actual number of amputated digits, according to the study. Of the 183 frozen fingers 22 were eventually amputated, nearly half of which belonged to patients who did not receive Aurlumyn infusions. In the Aurlumyn-alone group, no fingers were amputated.
Of the 224 frozen toes, 25 required amputations, 34% of which were in the group that did not receive Aurlumyn treatment. As in the case of fingers, none of the Aurlumyn-treated patient required toe amputations.
In terms of safety, Aurlumyn’s most common side effects are headache, palpitations, dizziness, flushing, hypotension, nausea, fast heart rate and vomiting.
