First FDA-Approved Treatment for Severe Frostbite Now Commercially Available in the US

SERB Pharmaceuticals recently announce Aurlumyn (iloprost) Injection, the first FDA-approved treatment for severe frostbite in adults to reduce the risk of digit amputations, is now commercially available in the US.

Aurlumyn will be formally launched during this week’s American Society of Health-System Pharmacists (ASHP) Midyear Clinical Meeting & Exhibition. ASHP meeting attendees can learn more about Aurlumyn by visiting booth 339.

Dr. Jennifer Dow, Emergency Medicine physician at Alaska Regional Hospital and Medical Director for the Alaska Region of the National Park Service, said “This marks a significant milestone in the field of frostbite treatment in the United States, and represents a new era of hope for patients at risk of digit amputations. Frostbite can be a debilitating condition that can lead to devastating consequences for patients. We hope Aurlumyn will revolutionize the standard of care and provide physicians with an essential tool to treat this condition and reduce the risk of amputations.”

Thomas Kolaras, Executive Vice President and US Chief Commercial Officer, added “We are proud to make Aurlumyn™ available to hospitals, first responders, and military customers in the US. This treatment empowers healthcare professionals to act decisively in critical moments, delivering hope and effective care to those at risk of life-altering complications.”

Studies show that thousands of people are hospitalized with frostbite in the US each year. This rare but highly debilitating condition most often affects winter sports enthusiasts, military personnel, outdoor workers, and the unhoused. Frostbite is a high morbidity, high-cost injury that can lead to digit or limb necrosis requiring amputation. Aurlumyn is indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations.

The most recent Wilderness Medical Society Clinical Practice Guidelines for the Prevention and Treatment of Frostbite strongly recommends considering Aurlumyn as a first-line therapy for Grades 3 and 4 frostbite <48 hours after thawing, and possibly for up to 72 hours.

SERB is a global specialty pharmaceutical company with a growing portfolio of medicines for emergency care and rare diseases. For over 30 years we have made treating these complex and life-threatening conditions possible, supporting clinicians, healthcare systems and governments while offering hope to patients and their families. SERB is a leading provider of essential acute care medicines, addressing unmet medical needs and supplying antidotes and medical countermeasures for chemical, biological, radiological and nuclear (CBRN) risks. As a fully integrated company, we have the experience and capabilities to acquire, develop, and manufacture our medicines to the highest standards, and make them available worldwide through our secure supply chain. For more information, visit https://SERB.com.

Aurlumyn is a prostacyclin mimetic and acts as a vasodilator (a drug that opens blood vessels) and inhibits platelet aggregation. Aurlumyn is indicated for the treatment of severe frostbite in adults to reduce the risk of digit amputations. Effectiveness was established in young, healthy adults who suffered frostbite at high altitudes. Aurlumyn was granted priority review and orphan drug designation (ODD) and was approved by the FDA in February of 2024 for the treatment of severe frostbite in adults to reduce the risk of digit amputations. A published case series review showed that Aurlumyn can be effective up to 72 hours after rewarming of a frostbite patient begins. Aurlumyn is available through specialty distribution by FFF Enterprises Inc. Customers interested in ordering can call 1-800-843-7477 or visit https://biosupply.fffenterprises.com. For more information, visit https://aurlumyn.com/.