AbbVie’s SKYRIZI™ Approved by FDA

| By | AbbVie, FDA Approved

AbbVie, a research-based global biopharmaceutical company, announced that the U.S. Food and Drug Administration (FDA) approved SKYRIZI™ (risankizumab-rzaa), an interleukin-23 (IL-23) inhibitor, for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy or phototherapy. In clinical trials, SKYRIZI produced high rates of durable skin clearance – most people (82 and 81 percent) treated with SKYRIZI achieved 90 percent skin clearance (PASI 90) at one year, with the majority (56 and 60 percent) achieving complete skin clearance (PASI 100).

The complex nature of psoriasis and the variability or loss of treatment response over time can prevent some patients from achieving their treatment goals. In clinical trials, risankizumab demonstrated high levels of skin clearance that persisted through one year. I’m pleased the dermatology community now has a new option that can help patients achieve and maintain a high level of treatment response,

said Kenneth B. Gordon,
M.D., a principal investigator
for the ultIMMa-1 pivotal trial and
professor and chair of dermatology
at the Medical College of Wisconsin.

The recommended dose for SKYRIZI is 150mg – administered by two subcutaneous injections every 12 weeks following two initiation doses at week 0 and 4. SKYRIZI can be administered in-office or by self-injection after training.

The approval of SKYRIZI is an important advance in the treatment of adults with plaque psoriasis who are seeking high levels of durable skin clearance that can be maintained over time. SKYRIZI builds on AbbVie’s legacy in immunology, expanding our portfolio to help meet the evolving needs in psoriatic disease and reinforcing our continued pursuit of innovations that improve care for people living with immune-mediated conditions,

said Michael Severino, M.D.,
vice chairman and president, AbbVie.

Affecting 7.5 million Americans, psoriasis is the most prevalent autoimmune disease in the U.S.4 It is characterized by over activation of the immune system and widespread inflammation that causes painful, itchy plaques anywhere on the skin.5 People with psoriasis also experience a significant emotional, psychological and social burden that can negatively impact their quality of life.

People living with plaque psoriasis can be profoundly impacted by their disease both physically and emotionally. The approval of a new therapy represents an important step forward in the treatment of psoriasis, offering dermatologists another option to help patients achieve their treatment goals,

said Stacie Bell, Ph.D., vice president
of research and medical affairs, National Psoriasis Foundation.

The approval of SKYRIZI is supported by results from AbbVie’s global Phase 3 psoriasis program, which assessed the safety and efficacy of SKYRIZI in adults with moderate to severe plaque psoriasis across four randomized, placebo and/or active-controlled pivotal studies: ultIMMa-1, ultIMMa-2, IMMhance and IMMvent. The co-primary endpoints of these studies were Psoriasis Area and Severity Index (PASI 90) and static Physician Global Assessment [sPGA] score of clear or almost clear [sPGA 0/1] at 16 weeks versus placebo.

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