The FDA’s decision is based on positive results from two induction and one maintenance clinical study of AbbVie’s Skyrizi for Crohn’s disease.
Courtesy of AbbVie Inc. All rights reserved
The U.S. Food and Drug Administration has awarded its first approval in the specific interleukin-23 inhibitor space for Crohn’s disease to AbbVie’s Skyrizi (risakizumab-rzaa).
Skyrizi now has the green light for use in adults with moderately to severely active Crohn’s disease. The drug works by blocking IL-23 by binding to its p19 subunit. IL-23 is active in inflammatory processes observed in many chronic immune-mediated illnesses. Patients receive 600 mg of the drug via IV for at least an hour at weeks zero, four and eight, and then every eight weeks after at 360 mg via self-administered subcutaneous injection.
The FDA’s decision is based on positive results from two induction (ADVANCE and MOTIVATE) and one maintenance (FORTIFY) clinical study, where Skyrizi demonstrated the ability to improve endoscopic response or a decrease of over 50% from baseline Simple Endoscopic Score in CD. The drug also delivered a better clinical remission response versus the placebo, as measured by the Crohn’s Disease Activity Index, among other positive outcomes.
The FDA is also reviewing a maintenance dose option of a 180 mg self-administered subcutaneous injection and may announce a decision soon.
“We are proud to offer the first new treatment option in six years for moderately to severely active CD, which may provide patients with a meaningful level of endoscopic improvement,” Thomas Hudson, M.D., senior vice president for research and development and chief scientific officer at AbbVie commented.
In addition to Crohn’s disease, Skyrizi is U.S. FDA-approved for use on moderate to severe plaque psoriasis in adults who qualify for systemic therapy or phototherapy and in adults with active psoriatic arthritis. In January 2022, the FDA gave its go-ahead for the said indication based on the success of two Phase III trials: KEEPsAKE-1 and KEEPsAKE-2. Skyrizi is also being tested in an ongoing trial for ulcerative colitis.
The latest FDA approval for CD is excellent news for AbbVie, which is likely seeking a new lead product, given the attention that Humira enjoyed. Humira, a drug for moderate to severe rheumatoid arthritis, posted a 9.1% drop in net revenues when the company reported fourth-quarter and full-year 2021 financial results in February. The product will begin to lose its exclusivity and patent protection once biosimilar products from competitors start to enter the market in 2023.
“Skyrizi and Rinvoq (also for rheumatoid arthritis) will be commercialized across all of Humira’s major indications — plus atopic dermatitis. We expect combined peak sales for Skyrizi and Rinvoq to exceed the peak revenues achieved by Humira,” AbbVie Chairman and Chief Executive Rick Gonzales said in an earlier statement.
Skyrizi and Rinvoq delivered $4.6 billion in combined sales in 2021 and are expected to rake in even more as new indications are introduced, including ulcerative colitis, ankylosing spondylitis and non-radiographic axial spondyloarthritis (SpA). Featured Jobs on BioSpace
