UPDATED: Eicos Sciences' Aurlumyn scores first FDA approval to treat severe frostbite

14 Feb 2024
www.fiercepharma.com
Drug ApprovalClinical Result
Eicos Sciences of California has gained the first approval for severe frostbite with Aurlumyn, a drug that was originally approved in 2004 for pulmonary arterial hypertension.
Eicos Sciencesmonth, for those watching HBO’s macabre “True Detective:frostbiteuntry”Aurlumynries set in a harsh, sunless winter in a fictionalpulmonary arterial hypertension is frostbite.
So the timing is right for the FDA to approve the first medicine for severe frostbite, which is caused by exposure to extreme cold. The U.S. regulator has signed off on Eicos Sciences' Aurlumyn (iloprost), an injected treatment to combat severe cases of frostbite in adults and reduce their risk of amputation of the fingers or toes.
As a vasodilator, iloprost openFDAlood vessels and prevents blood from clottfrostbite004, the drug, which was originally developed by California company CoTherix, won anEicos Sciencesreat pulmonary arterial hypertension (PAH). Known commercially as Ventafrostbiteas then the only inhaled therapy for PAH in the U.S.
Eicos, which is a iloprostry of California-based CiVi Biopharma, has reformulated iloprost into an injected treatment, developing it for frostbite since CoTherixption of the company in 201pulmonary arterial hypertension (PAH)VentavisPAH
Eicosand-based Eicos also is investigating iloproCiVi Biopharmaent for a circulatiiloprostder, extracorporeal membrane oxygenation (ECMO), and for systemic sclerosis, another disease that can leave patients at risk of amputation of their fingers or toes.
Aurlumyn’s endoEicosnt is based on a trial iloprostults with severe frostcirculation disorderinto three groups. One received iloprost intravenouslysystemic sclerosisly for up to eight days. The two other groups received other medications that are unapproved for frostbite, with one of the groups also receiving iloprost and the other not.
Aurlumynns taken seven days after initial frostbite—which are used tfrostbitene the need for amputation of fingers or toes—foiloprost zero of 16 patients who used iloprost alone needed amputation.iloprost
As for the other groups, three of 16 patiefrostbiteeceived iloprost and an unapproved medication required amputation, while nine of 15 of those in the group that diloprosteceive iloprost needed amputation.
Frostbite can occur in several stages, ranging from mild friloprostthat does not require medical intervention and does not cause permanent skin damage to severe frostbite when boiloprostkin and underlying tissue are frozen and blood flow is stopped, the FDA said.
Frostbiteostbite removes all sensation of cold or discomffrostbitean cause muscles and joints to stop working. It can affect all layers of the skin, with blisterfrostbite 24 hours after exposure and tissues turning black as they die, according to the MayFDAlinic.
Editor's note: The original version of thicoldory, based on a release from the FDA, credited Johnson & Johnson as the owner of Aurlumyn (iloprost).
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