The United States Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for United States-based Verrica Pharmaceuticals Inc's (Nasdaq: VRCA), VP-102 (cantharidin 0.7% Topical Solution), a proprietary topical therapy intended for the treatment of contagious viral skin disease molluscum contagiosum (molluscum), it was reported yesterday.
The Prescription Drug User Fee Act (PUDFA) goal date assigned by the US FDA for this NDA is 13 July 2020.
The NDA is based on positive results from two identical Phase three randomised, double-blind, multicentre clinical trials (CAMP-1 and CAMP-2) that assessed the safety and efficacy of VP-102 compared to placebo in patients two years of age and older diagnosed with molluscum. In both trials, a clinically and statistically significant number of patients treated with VP-102 met the primary endpoint of complete clearance of all treatable molluscum lesions.
Samsung Bioepis to assume European commercialisation of BYOOVIZ (ranibizumab) from January 2026
Thermo Fisher Scientific to acquire Clario Holdings, expanding clinical data capabilities
Shanton Pharma completes SAP-001 End-of-Phase 2 meeting with US FDA
Eli Lilly's single-injection, once-monthly maintenance Omvoh regimen receives US FDA approval
Spinogenix to present SPG601 Phase 2a trial results at AACAP Conference
AnnJi Pharmaceutical secures FDA Fast Track Designation for AJ201 in rare neuromuscular disease
Myosin Therapeutics' MT-125 granted US FDA Fast Track designation in glioblastoma
Boehringer Ingelheim's JASCAYD (nerandomilast) IPF treatment gains Chinese regulatory approval