How could the FDA approval of a Skyrizi regimen affect Amgen?
Skyrizi's expanded approval may increase competition for Amgen in Crohn's disease The FDA's approval of a subcutaneous induction regimen for Skyrizi expands its market reach and convenience for treating moderate to severe Crohn's disease. This new regimen allows patients to start induction therapy at home using an on-body injector induction pack. The approval is supported by the AFFIRM trial, which showed that subcutaneous induction resulted in a clinical remission rate of 55% compared to 29.6% for placebo. This enhanced efficacy and patient convenience increases the competitive pressure on other biopharmaceutical companies, including Amgen, that offer treatments for the same patient population.
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How it reaches Amgen
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The FDA approved a subcutaneous induction regimen of risankizumab (Skyrizi) for adults with moderate to severe Crohn’s disease. This approval expands the previous authorization, which was for an intravenous induction followed by subcutaneous maintenance. The new regimen allows patients to begin induction therapy at home using an on-body injector induction pack.
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The new subcutaneous induction regimen demonstrated high efficacy in the AFFIRM trial, achieving a clinical remission rate of 55% and an endoscopic response rate of 44%. This combination of high efficacy and increased patient convenience puts greater competitive pressure on other biopharmaceutical companies, such as Amgen, that market treatments for Crohn’s disease.
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The facts so far
As reported. Each one links to where it comes from.
- The FDA approved a subcutaneous induction regimen of risankizumab for adults with moderate to severe Crohn’s disease.healio.com
- The AFFIRM trial showed clinical remission at week 12 was 55% for subcutaneous induction versus 29.6% for placebo.healio.com
- The subcutaneous induction regimen allows patients to start treatment from home with an on-body injector induction pack.healio.com
Why it matters
The market for treatments for inflammatory bowel disease (IBD) is highly competitive, relying heavily on the development of effective and convenient biologic therapies. For companies like Amgen, which operate in the same therapeutic space, the introduction of a highly effective, at-home induction regimen by a major competitor represents a significant shift in market dynamics. This forces companies to continually innovate in both drug efficacy and delivery methods to maintain market share.
The approval builds on the strong efficacy of Skyrizi, which was initially approved in 2022 for this patient population. The success of the AFFIRM trial, which involved 289 adults, validates the potential of interleukin-23 p19 agents, setting a high bar for future treatments and increasing the stakes for all players in the IBD drug market.
What we don't know yet
- How will Amgen respond to the increased competition from the expanded Skyrizi regimen?
- Will the convenience of at-home induction significantly change prescribing habits for Crohn's disease?
What would change this answer
Who else could feel it
Other possible ripples from the same event.
Reporting
- healio.comOct 23
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Brind's analysis is written by AI from the reporting linked above and can be wrong. This explainer is a possibility worth considering, not a forecast: steps marked as Brind's reasoning are not stated in the reporting. It is not investment advice; do your own research.