AbbVie's New Dermatology Drug Skyrizi Receives FDA Approval for Plaque Psoriasis Treatment

VCBeat (WeChat Official Account: vcbeat) learned from foreign media that AbbVie, a biopharmaceutical company based in Chicago, USA, recently announced that its new dermatological drug, Skyrizi, has received FDA approval for systemic treatment or phototherapy in patients with severe psoriasis and plaque psoriasis.

Plaque psoriasis is the most common form of psoriasis, affecting approximately 7.5 million patients in the United States. As an autoimmune disease, it causes red skin lesions known as plaques, which can lead to itching and pain.

AbbVie’s dermatology portfolio for the treatment of psoriasis extends beyond Skyrizi. The company previously launched Humira, a “super blockbuster” drug for plaque psoriasis and other immune-mediated diseases, which generated $19.94 billion in revenue for AbbVie in 2018. However, AbbVie anticipates that Humira will face intense competition from biosimilars starting in 2023, leading to an expected decline in sales. To offset this revenue gap, AbbVie introduced Skyrizi, a new dermatology agent, with projected annual sales estimated at $4 billion to $5 billion.

Skyrizi is an interleukin-23 (IL-23) inhibitor. IL-23 is believed to be associated with several chronic immune-mediated diseases, including psoriasis and inflammatory conditions. Skyrizi selectively blocks IL-23 by binding to its p19 subunit, thereby treating related dermatological conditions.

Skyrizi has been approved in the United States and Canada for the treatment of moderate-to-severe plaque psoriasis. In Japan, it has been approved for patients with plaque psoriasis, generalized pustular psoriasis, erythrodermic psoriasis, and psoriatic arthritis who have had an inadequate response to conventional therapies. Approval is expected this year in the European Union for the treatment of patients with moderate-to-severe plaque psoriasis. Currently, AbbVie is evaluating the efficacy of Skyrizi in Crohn’s disease, psoriatic arthritis, and ulcerative colitis in Phase III clinical trials.

Skyrizi is not a drug independently developed by AbbVie; rather, AbbVie acquired it from the biotechnology company Boehringer Ingelheim in 2016 for $2.595 billion. Other similar dermatological medications currently on the market include Cosentyx, Stelara, Taltz, and Tremfya. Among these, Tremfya, like Skyrizi, is an IL-23 inhibitor; the difference lies in the dosing frequency, with Tremfya administered every two months and Skyrizi every three months. In 2017, AbbVie tested Skyrizi for the treatment of psoriasis, demonstrating efficacy that surpassed existing dermatological drugs on the market, namely Stelara and Humira.

In clinical trials, Skyrizi demonstrated high and durable skin clearance rates, with over 80% of patients achieving a 90% reduction in skin lesions after one year of treatment. Following comparative dose-ranging studies, AbbVie recommends administering the drug at Week 0 and Week 4, followed by maintenance dosing every 12 weeks. Each dose consists of two subcutaneous injections of 75 mg each, for a total dose of 150 mg, supporting both administration in healthcare settings and self-administration.

“The complex nature of psoriasis and its prolonged treatment course can cause many patients to lose confidence in achieving a cure,” said Professor of Dermatology Kenneth B. Gordon. “The exceptionally high clearance rates demonstrated by Skyrizi in clinical trials offer a new therapeutic option for patients with skin diseases, enabling them to achieve favorable treatment outcomes and sustain high levels of treatment response.”

It is reported that Skyrizi will be officially launched in May this year.

(Compiled by Wang Chan)