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In Brief: Penederm Avita

This article was originally published in The Rose Sheet

Executive Summary

Penederm Avita: Firm submits to FDA July 16 results from a three-month, 675-patient clinical study showing "statistically significant efficacy at the 95% confidence level" for its anti-acne retinoic acid gel treatment Avita. The study compared Avita to J&J's Retin-A and placebo in four efficacy parameters -- total lesions, inflammatory lesions, noninflammatory lesions and global assessment. Penederm is submitting the results as an amendment to its NDA for Avita after receiving a "non-approvability" letter from FDA for the prescription acne drug. The agency requested additional data on the noninflammatory lesion endpoint, stating that results from Penederm's second clinical study did not replicate those from the first study. The Foster, Calif.-based company said that the results from the third study "address...the clinical issue raised" in FDA's action letter. A second action letter regarding the cream formulation of Avita stated that approval of that product is dependent on approval of the gel version...
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