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March 27, 2019

AbbVie receives regulatory approval for plaque psoriasis drug in Japan

AbbVie has obtained approval from the Japanese Ministry of Health, Labour and Welfare for the use of the drug Skyrizi to treat plaque psoriasis.

AbbVie has obtained approval from the Japanese Ministry of Health, Labour and Welfare for the use of the drug Skyrizi to treat plaque psoriasis.

The approval also allows the use of the drug for treating generalised pustular psoriasis, erythrodermic psoriasis and psoriatic arthritis in adults who experience an inadequate response to standard therapies.

This is the first regulatory approval globally for the drug, a humanised immunoglobulin G1 (IgG1) monoclonal antibody intended to bind to and selectively inhibit IL-23, the protein that causes the overproduction of skin cells leasing to psoriasis symptoms.

AbbVie is developing Skyrizi as part of an alliance with Boehringer Ingelheim.

The approval comes after a review of safety and efficacy results from sustaIMM, ultIMMa-1 and IMMspire clinical trials that assessed the drug in plaque psoriasis, generalised pustular psoriasis and erythrodermic psoriasis patients.

“Skyrizi has the potential to improve the signs and symptoms of these chronic, immune-mediated diseases.”

The approval is based on findings from a Phase II trial in patients suffering from active psoriatic arthritis.

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AbbVie vice-chairman and president Michael Severino said: “With this first global approval of Skyrizi, we are excited to bring a new treatment option to people living with the psoriatic disease in Japan.

“Skyrizi has the potential to improve the signs and symptoms of these chronic, immune-mediated diseases. We look forward to continuing to work with regulatory authorities to make this treatment available to more patients worldwide.”

Last month, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the approval of the drug for moderate to severe plaque psoriasis in adults eligible for systemic therapy.

Skyrizi is also being reviewed by the US Food and Drug Administration (FDA) and a decision is expected in the first half of this year.

Psoriasis is a chronic, inflammatory disease leading to inflamed, scaly patches that cause itchiness, burning and stinging. The condition often results in the development of psoriatic arthritis, which is characterised by irreversible joint deformations and disability.

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