Ortho Dermatologics announces FDA acceptance of NDA filing for IDP-126 Gel

Bausch Health Companies announced that the U.S. Food and Drug Administration has accepted the New Drug Application for investigational IDP-126 Gel with a Prescription Drug User Fee Act action date of October 20, 2023. If approved, IDP-126 has the potential to be the first of its kind fixed dose triple combination treatment for acne vulgaris. The NDA submitted for IDP-126 includes data from two successfully completed Phase 3 multicenter, randomized, placebo controlled clinical trials in 363 patients with acne vulgaris. Both studies met all co-primary efficacy endpoints, including absolute change from baseline in inflammatory lesion count, absolute change from baseline in non-inflammatory lesion count and percentage of patients achieving treatment success. Both studies showed treatment-emergent adverse events were of mild to moderate severity.