Frostbite

The FDA approved Eicos Sciences’ injectable vasodilator Aurlumyn (iloprost) for the treatment of severe frostbite in adults, making it the first drug to be authorised in this indication.“Having this new option provides physicians with a tool that will help prevent the life changing amputation of one’s frostbitten fingers or toes,” remarked Norman Stockbridge, director of the Division of Cardiology and Nephrology in the FDA’s Center for Drug Evaluation and Research. The approval was supported by findings from a study involving 47 adults with severe frostbite, all having received intravenous aspirin and standard care. Participants were randomly assigned to receive Aurlumyn alone, or other medications that are unapproved for frostbite either alone or in combination with Eicos’ drug. The primary endpoint was a bone scan performed seven days after the onset of frostbite, with the goal of establishing the need for amputation of at least one finger or toe.At day seven, none of the patients given Aurlumyn alone had a bone scan indication for amputation, compared with 19% in those administered Eicos’ drug in combination with other medicines and 60% in the third group. In addition, the Aurlumyn groups had significantly fewer patients with bone scan abnormalities, and the majority of patients’ subsequent amputation status at follow-up was consistent with the bone scan findings. The FDA noted that Aurlumyn’s label carries a warning and precaution highlighting a risk of symptomatic hypotension. Iloprost gained its first FDA approval back in 2004 as an inhaled therapy for the treatment of pulmonary arterial hypertension under the brand Ventavis. Eicos, a subsidiary of CiVi Biopharma, has reformulated the drug into an intravenous form and is also investigating it for systemic sclerosis and as an anticoagulant in patients receiving extracorporeal membrane oxygenation.

Pictured: FDA signage at its office in Maryland/iStock, hapabapa 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. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. Reach out to him on LinkedIn or email him at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Aurlumyn injection is a new treatment option for adults with severe frostbite. Credit: movchanzemtsova / Shutterstock.com. The US Food and Drug Administration (FDA) has approved Eicos Sciences’s Aurlumyn (iloprost) injection, a new treatment for adults with severe frostbite to lower the risk of amputation of fingers or toes. Aurlumyn contains iloprost, a vasodilator that opens blood vessels and stops blood clotting, as its active ingredient. The efficacy of iloprost in treating severe frostbite was established through an open-label controlled trial in 47 adult subjects. Participants were randomised into three groups, with group one receiving iloprost intravenously for six hours daily for up to eight days along with aspirin and standard of care. Groups two and three were administered other medications, with and without iloprost, which are not approved for frostbite treatment. See Also: Otsuka wins FDA breakthrough therapy designation for IgAN drug QBiotics wins FDA orphan status for rainforest-derived cancer drug The trial’s primary efficacy measure was bone scans on day seven following the frostbite incident to predict the need for amputation. The scans showed that none of the subjects who received iloprost alone (group one) required amputation compared to 19% in group two and 60% in group three. This indicated a significant reduction in the presence of bone scan abnormalities in groups receiving iloprost. Most subjects had follow-up data available to confirm whether they underwent amputation. This aligned with the bone scan findings. Headache, flushing, heart palpitations, nausea and hypotension were common side effects linked to Aurlumyn treatment. The treatment carries a warning for potential symptomatic hypotension. Aurlumyn was granted priority review and orphan drug designations for this indication, highlighting its significance in addressing severe frostbite, a condition that can escalate from mild to severe, potentially leading to permanent tissue damage and the cessation of blood flow. Iloprost originally received approval in 2004 for pulmonary arterial hypertension. FDA Center for Drug Evaluation and Research Division of Cardiology and Nephrology director Norman Stockbridge stated: “This approval provides patients with the first-ever treatment option for severe frostbite. “Having this new option provides physicians with a tool that will help prevent the life-changing amputation of one’s frostbitten fingers or toes.”