Posted by Michael Wonder on 22 Dec 2018
Foamix submits new drug application to U.S. FDA seeking approval of FMX101 in treatment of moderate-to-severe acne
21 December 2018 - Foamix Pharmaceuticals today announced that it has submitted a new drug application to the U.S. FDA seeking approval for FMX101 for the treatment of inflammatory lesions of non-nodular moderate-to-severe acne vulgaris in patients 9 years of age and older.
The submission is supported by the previously communicated results from two Phase 3 trials, FX2014-05 and FX2017-22. In these trials, FMX101 met both co-primary endpoints, demonstrating statistically significant improvements in inflammatory lesion count and Investigator Global Assessment (IGA) treatment success. In these trials, the safety profile of FMX101 was generally favourable and consistent throughout the clinical development program.
