Biopharmaceutical company Mycovia Pharmaceuticals Inc announced on Tuesday that long-term efficacy results from an extension study of the VIOLET Phase 3 clinical programme, which evaluated VIVJOA (oteseconazole) capsules in women with recurrent vulvovaginal candidiasis (RVVC), has been published in Journal of Women's Health.
The product is the first and only available FDA-approved therapy for RVVC, or chronic yeast infections, in post-menopausal women or women who are not of reproductive potential.
The VIOLET studies, two Phase 3 multi-centre, multi-national, double-blind, randomised, placebo-controlled clinical trials, assessed the efficacy and safety of VIVJOA in women with RVVC and provided pivotal data supporting US approval of VIVJOA for RVVC in 2022.
VIVJOA was demonstrated to be statistically superior to placebo in reducing culture-verified VVC infections through 48 weeks, with up to 96% of women receiving VIVJOA remaining infection free compared to 61% receiving placebo.
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Lupin launches Dasatinib tablets in US market
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA
FDA approves Tenpoint Therapeutics' YUVEZZI as first dual-agent eye drop for presbyopia
Summit Therapeutics' BLA for ivonescimab in EGFR-mutated NSCLC accepted by FDA
WuXi Biologics collaborates with Sinorda Biomedicine for antibody development
Biogen's litifilimab receives FDA Breakthrough Therapy Designation for CLE
Glaukos receives FDA approval for repeat administration of iDose TR
Guerbet's contrast agent Elucirem approved by European Commission in children from birth
Spine Innovation's LOGIC Titanium Implant System receives US FDA 510(k) market approval