The US regulator will review a submission from LEO Pharma for approval to market tralokinumab in moderate-to-severe atopic dermatitis (AD). A target action date has been set for the second quarter of 2021.
The Danish dermatology specialist, which has been testing the interleukin (IL)-13 blocker in the Phase III ECZTRA program, submitted tralokinumab for approval in Europe in early June 2020.
LEO acquired rights to tralokinumab from AstraZeneca in 2016. If approved, it will be the first biologic to challenge Sanofi and Regeneron’s Dupixent (dupilumab), the current leading option.
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