Shots:
- The approval was based on the study evaluating the efficacy of Aurlumyn for treating patients (n=47) with severe frostbite, all received aspirin & SoC. Patients were divided into 3 treatment arms receiving Aurlumyn (IV, 6hrs., daily for up to 8 days) alone in arm 1 & unapproved medications with/without Aurlumyn in arms 2 & 3
- The 1EP was a bone scan taken 7 days post initial frostbite for predicting the need for amputation of at least 1 finger or toe
- The results, on day 7, demonstrated the need for amputation in 0% of patients across arm 1 vs 19% & 60% of them in arms 2 & 3 respectively with a lesser presence of the bone scan abnormality in the groups receiving Aurlumyn
Ref: FDA | Image: Eicos Sciences | Press Release
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