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Japanese authorities approve AbbVie's SKYRIZI.

M2 EQUITYBITES-March 28, 2019-Japanese authorities approve AbbVie's SKYRIZI

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The Japanese Ministry of Health, Labour and Welfare has approved United States-based AbbVie's SKYRIZI (risankizumab), an interleukin-23 (IL-23) inhibitor, it was reported yesterday.

The product is intended for the treatment of plaque psoriasis, generalised pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adult patients who have an inadequate response to conventional therapies. SKYRIZI is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and commercialisation of SKYRIZI globally.

This approval is the first country approval in the world for SKYRIZI. The approval is based on efficacy and safety data from Phase two and Phase three clinical trials, sustaIMM, ultIMMa-1 and IMMspire, evaluating SKYRIZI in Japanese patients with plaque psoriasis, generalised pustular psoriasis and erythrodermic psoriasis, and a global Phase two study in patients with active psoriatic arthritis.

SKYRIZI is currently under review with the US Food and Drug Administration (FDA) and a regulatory decision is anticipated in the first half of 2019.

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Date:Mar 28, 2019
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