Xiaflex meets primary endpoints for Peyronie's - Auxilium Pharma
New data from the IMPRESS Phase III studies that assessed Xiaflex (collagenase clostridium histolyticum or CCH), from Auxilium Pharmaceuticals, for the potential treatment of Peyronie's disease (PD) have met both co-primary endpoints of change in penile curvature deformity (PCD) and PD symptom bother with statistical significance compared to baseline. The mean percent change in PCD was 34.4 percent and the mean change in PD symptom bother score was 3.3 from baseline.
In addition, a study of different subgroups of men treated with Xiaflex based on their prior PD treatment, erectile dysfunction scores and prostatectomy history shows that the clinical outcomes related to PCD and PD bother did not vary among these subgroups. The Company's supplemental Biologics License Application for Xiaflex for the treatment of PD is currently under review at the FDA.
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