AbbVie’s Skyrizi Receives NICE Approval for Plaque Psoriasis in the UK, Bolstering Post-Humira Strategy

July 15, 2019/BioValleyBIOON/--U.S. biotechnology giant AbbVie has received positive regulatory news in the UK for its novel anti-inflammatory drug Skyrizi (risankizumab-rzaa). The UK’s National Institute for Health and Care Excellence (NICE) has issued a positive Final Appraisal Document (FAD), recommending Skyrizi for adult patients with severe psoriasis who have failed to respond to conventional systemic therapies. This recommendation means that the UK’s National Health Service (NHS) will begin providing Skyrizi to eligible patients starting in August.

Psoriasis is a highly competitive therapeutic area. Skyrizi, a newer agent in the IL-23 inhibitor class, offers a dosing advantage over other IL-23 inhibitors: it is administered once every three months (12 weeks), whereas competing IL-23 inhibitors require monthly (4-week) dosing. In clinical trials, Skyrizi demonstrated high and durable skin plaque clearance rates. After one year of treatment, the majority of patients (82% and 81%) achieved 90% skin plaque clearance (PASI 90), and more than half (56% and 60%) achieved complete skin plaque clearance (PASI 100).

In the final appraisal, NICE noted that,Clinical TrialData show that Skyrizi is more effective than AbbVie’s anti-inflammatory drug Humira (adalimumab) and Johnson & Johnson’s IL-12/IL-23 inhibitor Stelara (ustekinumab). Furthermore, indirect comparisons suggest that Skyrizi may provide similar health benefits to Johnson & Johnson’s IL-23 inhibitor Tremfya (guselkumab), while offering higher PASI response rates compared with many other biologics.

The recent NICE review outcome is major good news for AbbVie. Humira, AbbVie’s flagship product with annual sales nearing $20 billion, saw its patent expire in the European market last October, and it is now facing multipleBiosimilarsencirclement and suppression. Skyrizi will have the opportunity to offset part of the losses. In the 2017/2018 fiscal year, Humira was the largest drug expenditure for the UK NHS to date, reaching £495 million, but spending on this drug is set to decline this year. Among other newer products, Johnson & Johnson’s Stelara had the highest prescription volume, with expenditures of £32 million during the same period, representing a 25% increase.

Psoriasis is the most common type ofAutoimmunityPsoriasis is characterized by immune system overactivation and widespread inflammation, leading to painful, itchy plaques appearing anywhere on the skin. In addition, patients with psoriasis also experience significant emotional, psychological, and social burdens, which may exacerbate skin pain and itching and severely impact their quality of life.

The active pharmaceutical ingredient of Skyrizi is risankizumab, a monoclonal antibody that selectively blocks interleukin-23 (IL-23), an immune inflammatory mediator in the body, by specifically targeting the IL-23p19 subunit. IL-23 is a cytokine believed to play a key role in many chronic immune-mediated diseases. Risankizumab was originally developed by the German pharmaceutical company Boehringer Ingelheim (BI). In February 2016, AbbVie acquired the global commercialization rights to risankizumab with an upfront payment of $600 million.

In the first half of this year, Skyrizi was successively approved in Japan, the United States, and the European Union for the treatment of adult patients with moderate-to-severe plaque psoriasis. Currently, Phase III clinical trials are underway for Skyrizi in the treatment of Crohn’s disease and psoriatic arthritis. Additionally, AbbVie is evaluating Skyrizi for the treatment of ulcerative colitis and other inflammatory conditions.ImmunologyDisease.

Skyrizi is entering a highly crowded market, where it will compete with multiple drugs, including:NovartisCosentyx and Ilaris,Eli Lillysuch as Eli Lilly’s Taltz, Valeant’s Siliq, Johnson & Johnson’s Tremfya, and Sun Pharmaceutical’s Ilumya. Among these drugs, Tremfya and Ilumya are also biologic therapies that selectively target IL-23. Nevertheless, despite all this competition, the industry remains highly optimistic about the commercial prospects of Skyrizi. SVB Leerink analysts predict that Skyrizi’s annual peak sales will reach $3 billion.

In addition to Skyrizi, AbbVie has another late-stage asset in the inflammation and autoimmune disease field that has drawn significant industry attention: upadacitinib. This oral JAK inhibitor demonstrated superior efficacy to Humira in recent head-to-head clinical trials. Currently, upadacitinib for the treatment of rheumatoid arthritis is under review by regulatory authorities in the United States and Europe, while its applications for psoriatic arthritis, Crohn’s disease, atopic dermatitis, and ulcerative colitis are in Phase III clinical trials. The industry holds strong optimism regarding the commercial prospects of upadacitinib. A previously released report by the pharmaceutical market research firm EvaluatePharma predicted that global sales of upadacitinib would reach $2.57 billion in 2024, making it the fifth best-selling antirheumatic drug worldwide. (Bioon.com)

Original Source:AbbVie’s Skyrizi gets rapid ‘yes’ from NICE