FDA Approves Subcutaneous Induction Regimen for Skyrizi in Crohn's Disease
What happened
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.
From healio.com
Why it matters
The approval expands the market access for Skyrizi. Results from the AFFIRM trial, which supported the approval, showed that nearly twice as many patients who received the subcutaneous induction regimen achieved clinical remission at week 12 compared with placebo.
From healio.com
Who's involved
- FDARegulatory agency that granted the market approval for the drug.
- AbbViePharmaceutical company that manufactures Skyrizi, the approved drug.
- Center for Devices and Radiological HealthDivision of the FDA responsible for regulating medical devices and drugs.
Who could feel it
Possible knock-on effectsThese are possibilities Brind reasoned out, not predictions, and not advice. Most are not stated in any report.
- AbbVieSpeculative
AbbVie could see increased revenue and market access due to the expanded regulatory approval for Skyrizi.
Possible ripples
Who this could reach next, traced step by step from the reporting. Possibilities worth considering, not forecasts.- New Skyrizi regimen requires CDRH oversight of injector deviceCDRH must oversee the on-body injector device used in Skyrizi's new regimen.Likely
- Skyrizi approval expands CBER's oversight of biologic therapiesCBER's regulatory scope expands with approval of Skyrizi for Crohn's diseaseLikely
- Skyrizi's expanded approval may increase competition for Amgen in Crohn's diseaseSkyrizi's expanded approval may increase competition for Amgen in Crohn's diseasePossible