AbbVie passes MHLW approval for SKYRIZI for the treatment of psoriasis in Japan.
M2 PHARMA-March 26, 2019-AbbVie passes MHLW approval for SKYRIZI for the treatment of psoriasis in Japan
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Biopharmaceutical company AbbVie (NYSE:ABBV) revealed on Monday the receipt of approval from the Japanese Ministry of Health, Labour and Welfare (MHLW) for SKYRIZI for the treatment of plaque psoriasis, generalised pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adult patients in Japan.
This approval marks the first country approval in the world for SKYRIZI (risankizumab), an interleukin-23 (IL-23) inhibitor, for the treatment of psoriasis vulgaris, psoriatic arthritis, generalised pustular psoriasis, or erythrodermic psoriasis in adult patients who responded inadequately to conventional therapies..
Psoriasis is a chronic, non-communicable inflammatory condition characterised by inflamed, scaly patches that causes people to experience itchiness, burning and stinging. In Japan, 15% of individuals with psoriasis develop psoriatic arthritis, a chronic, inflammatory disease that leads to irreversible joint deformations and disability.
This MHLW approval is based on efficacy and safety data from the company's Phase 2 and Phase 3 clinical trials, sustaIMM, ultIMMa-1 and IMMspire, evaluating SKYRIZI in Japanese patients with plaque psoriasis, generalised pustular psoriasis and erythrodermic psoriasis, as well as a global Phase 2 study in patients with active psoriatic arthritis. SKYRIZI is part of a collaboration with Boehringer Ingelheim, with AbbVie leading development and commercialisation globally.
The company also disclosed that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for SKYRIZI for treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy in February 2019. It 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 26, 2019|
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