Healthcare company Bausch Health Companies Inc (NYSE/TSX:BHC) and its Ortho Dermatologics dermatology business reported on Thursday the receipt of approval from the US Food and Drug Administration (FDA) for the New Drug Application for DUOBRII Lotion, 0.01%/0.045% for the topical treatment of plaque psoriasis in adults.
Plaque psoriasis is a chronic, non-contagious skin disease that alters the life cycle of skin cells, causing them to build up rapidly on the surface of the skin.
According to Bausch Health, DUOBRII (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045% is the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation. A Phase 2 study demonstrated that the product was consistently more effective than its individual agents and vehicle in achieving treatment success.
In the company's year-long safety study, patients applied DUOBRII Lotion for up to 24 weeks of continuous use and up to 52 weeks of as-needed use.
Expected to be available in June 2019, DUOBRII Lotion is priced at USD825 for a supply of a 100-gram tube, which is more than 50% lower than other branded topical combination products. The company's access programme provides commercially insured patients with a co-pay between USD25 and USD40.
Relay Therapeutics wins FDA breakthrough status for zovegalisib in breast cancer treatment
DATROWAY receives US priority review for first-line metastatic triple negative breast cancer
Valneva and Instituto Butantan launch pilot chikungunya vaccination campaign in Brazil
Lupin launches Dasatinib tablets in US market
WuXi Biologics enters into licence and research service agreement with Vertex Pharmaceuticals
Natera submits Signatera CDx PMA to FDA for bladder cancer use
Pharming receives FDA complete response letter for paediatric Joenja application
Astrazeneca Imfinzi perioperative regimen gains positive EU CHMP opinion in early gastric cancer
I Peace generates human iPS cells from NKT cells and offers them for research use
Trace Biosciences' IND application for nerve-specific imaging agent approved by FDA
Frontage expands early phase clinical research capabilities across US and China
AstraZeneca agrees obesity and type 2 diabetes collaboration with CSPC
Ascletis Pharma Inc reports topline results from Phase III open-label study of denifanstat
Innovative Molecules GmbH completes Phase 1 clinical development programme for adibelivir
MicuRx Pharmaceuticals' IND application for MRX-5 cleared by FDA