Eicos’ Aurlumyn bags FDA approval as first-ever severe frostbite treatment

2024-02-16

上市批准临床结果

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.

更多内容，请访问原始网站

文中所述内容并不反映新药情报库及其所属公司任何意见及观点，如有版权侵扰或错误之处，请及时联系我们，我们会在24小时内配合处理。

机构

Eicos Sciences, Inc.