AbbVie’s psoriasis drug Skyrizi approved in Japan
AbbVie’s hotly anticipated psoriasis drug Skyrizi (risankizumab) has been approved in Japan, the first country to okay this potential blockbuster.
Skyrizi is important for AbbVie as sales of its Humira (adalimumab) inflammatory disease mega-blockbuster are being affected by cheaper biosimilar competitors outside the US.
This is the first approval by a regulator for Skyrizi, with the Japanese Ministry of Health Labour and Welfare granting a licence for plaque psoriasis, generalised pustular psoriasis, erythrodermic psoriasis, and psoriatic arthritis in adults who have not responded to conventional therapies.
The drug is one of several that AbbVie is depending on to replace sales lost as Humira loses its patent protection, which lasts until 2023 in the US but has expired in Europe late last year.
Despite this, revenues from Humira were almost $20 billion in 2018, thanks to its approval in a host of inflammatory diseases.
Skyrizi is a humanised immunoglobulin G1 (IgG1) monoclonal antibody, which works by selectively inhibiting IL-23 by binding to its P19 subunit.
It is part of a collaboration between Boehringer Ingelheim and AbbVie, with AbbVie leading development and marketing globally.
Skyrizi is currently under review with the US Food and Drug Administration (FDA), and AbbVie expects a regulatory decision in the first half of this year.
Approval in Europe is also highly likely after the European Medicines Agency’s CHMP scientific committee adopted a positive opinion in adults with severe plaque psoriasis in eligible adults last month.
Positive decisions from the CHMP are passed on to the European Commission, which nearly always grants a licence within a few months covering all 28 EU member states.
Approval in Japan is based on efficacy and safety data from 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.
Mamitaro Ohtsuki, chairman and professor at the Department of Dermatology, Jichi Medical University, said: “Advances in our understanding of psoriatic disease have brought us to an era where clear skin is a realistic treatment goal.
“Skyrizi has the potential to help psoriasis patients achieve high rates of skin clearance, bringing them closer to reaching long-term treatment goals with every 12-week dosing.”
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