Japan Nods Include Torii's Vtama, Skyrizi In New Uses

Concomitant Use Rules Also Revised

Japan issues approval recommendations in new indications, including Torii's Vtama in atopic dermatitis and AbbVie's Skyrizi in ulcerative colitis. Separately, filing requirements for the use of concomitant therapies have been revised.

Japan cautiously eased approval process for concomitant therapeutics used in combination therapy.
Japan cautiously eased approval process for concomitant therapeutics used in combination therapy. • Source: Shutterstock

An advisory committee to Japan’s Ministry of Health, Labour and Welfare (MHLW) has issued approval recommendations for a new batch of drugs including Dermavant Sciences Inc./JT Pharmaceuticals Inc/Torii Pharmaceutical Co. Ltd.’s Aryl hydrocarbon receptor (AhR) Vtama (tapinarof) for psoriasis vulgaris and atopic dermatitis, the latter being the global-first approval in this indication.

Other notable products receiving preliminary nods on 31 May included Novo Nordisk A/S’s Awiqli (once-weekly basal insulin icodec) for...

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