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AGI Dermatics Dimericine

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Company plans to file a BLA in June for the T4N5 liposome lotion for prevention of basal cell carcinoma and actinic keratosis in patients with xeroderma pigmentosum. The BLA will be based on a 30-patient, one-year study reported March 24 in The Lancet. The annualized rate of new AK lesions was 8.2 for Dimericine vs. 25.9 for placebo, while the rate of new basal cell carcinoma lesions was 3.8 vs. 5.4. AGI plans to file an IND soon for evaluation of Dimericine in people without xeroderma pigmentosum who have had at least one AK or basal cell carcinoma lesio
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