FDA approves at-home Skyrizi induction for Crohn's disease

Overview

Updated 1 hour ago

Since 2022, adults with moderately to severely active Crohn's disease have started Skyrizi with three intravenous infusions at weeks 0, 4 and 8, usually at a clinic. On October 23, the Food and Drug Administration approved a second path: 720 milligrams injected under the skin at weeks 0, 2, 4 and 8, given at home with an on-body injector.

The approval rests on AFFIRM, a Phase 3 trial that randomized 274 patients. At week 12, 56% of those on subcutaneous Skyrizi were in clinical remission against 30% on placebo. Among patients who had never failed an advanced therapy, 74% reached remission against 27%.

Why it matters

Patients can now begin a Crohn's biologic without scheduling a clinic infusion, moving the first months of treatment into the home.

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Key Indicators

56%

Clinical remission at week 12, subcutaneous Skyrizi

Versus 30% on placebo across the full AFFIRM trial population.

74%

Remission in patients new to advanced therapy

Versus 27% on placebo, in a subgroup of 65 treated patients.

43%

Endoscopic response at week 12

Versus 15% on placebo, measured by central review of bowel inflammation.

720 mg

Subcutaneous induction dose

Given at weeks 0, 2, 4 and 8; the IV option is 600 mg at weeks 0, 4 and 8.

274

Patients in the AFFIRM trial

Randomized 2:1 to subcutaneous Skyrizi or placebo; 65% had already failed an advanced therapy.

Voices

Curated perspectives — historical figures and your fellow readers.

People Involved

Roopal Thakkar

Chief Scientific Officer and head of research and development, AbbVie

Leading AbbVie's immunology pipeline

Organizations Involved

AbbVie (Allergan)

Pharmaceutical company

Manufacturer of Skyrizi (risankizumab-rzaa)

AbbVie developed and sells Skyrizi, one of its largest immunology products, and pushed for a home-injection route into the Crohn's market.

U.S. Food and Drug Administration

Federal regulator

Approved the subcutaneous induction regimen and revised TB testing language

The agency that reviews drug applications and sets the label language governing how Skyrizi can be prescribed.

Johnson & Johnson

Pharmaceutical company

Markets Tremfya, which had subcutaneous Crohn's induction first

J&J's Tremfya reached the Crohn's market with both subcutaneous and intravenous induction about 19 months before Skyrizi.

Timeline

2022 October 2026

5 events Latest: October 23rd, 2026 · 1 week ago

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October 2026
FDA approves subcutaneous induction for Skyrizi in Crohn's
Latest Approval

Patients can start at home with 720 mg at weeks 0, 2, 4 and 8 via an on-body injector, then continue every eight weeks.
October 23rd, 2026
FDA rewrites TB screening language across Skyrizi indications
Regulation

The label now lets clinicians decide whether tuberculosis testing is needed before starting treatment.
October 23rd, 2026
AbbVie releases 24-week AFFIRM endoscopic results
Data

35.8% of subcutaneous Skyrizi patients reached endoscopic remission after induction and maintenance, against 9.1% on placebo.
October 13th, 2026
March 2025
Tremfya offers Crohn's patients a subcutaneous start
Competition

Johnson & Johnson wins approval for guselkumab with both subcutaneous and intravenous induction.
March 2025
2022
Skyrizi enters the Crohn's market with IV-only induction
Approval

Risankizumab is cleared for moderately to severely active Crohn's disease, started with intravenous infusions at weeks 0, 4 and 8.
2022

Scenarios

Home induction becomes the standard start for Skyrizi in Crohn's

Likely Resolves by End of 2027

Discussed by: AbbVie executives and analysts following the immunology franchise

Gastroenterology practices already set up for self-injection move new patients onto the injector, and IV induction becomes reserved for patients who need supervised dosing. The trigger is payer coverage: if insurers reimburse the on-body injector pack without extra paperwork, prescribing shifts quickly.

Intravenous induction stays the default in practice

Possible Resolves by End of 2027

Discussed by: Gastroenterologists commenting on the trial design

The AFFIRM study did not compare subcutaneous and intravenous induction head to head, so no data show one route works better. Clinics that already have infusion capacity may keep using it, especially for patients who want a supervised first dose, leaving the injector as a secondary option.

Trial results in treatment-experienced patients limit enthusiasm

Uncertain Resolves by Q2 2027

Discussed by: Clinical readers of the AFFIRM subgroup data

About 65% of trial patients had already failed a biologic or JAK inhibitor, and in that group 45% reached remission against 31% on placebo. The 74% figure comes from 65 treated patients who had never failed advanced therapy, a small subgroup. If specialists focus on the harder-to-treat majority, adoption could be slower than the headline rate suggests.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

February 2007

Adalimumab brings self-injection to Crohn's disease (2007)

The FDA approved adalimumab (Humira) for Crohn's disease, giving patients a biologic they could inject at home with a prefilled pen instead of traveling for an intravenous infusion. Earlier Crohn's biologics were given in infusion suites.

Then

Gastroenterology practices built training programs around self-injection, and patients took on the dosing themselves.

Now

Home injection became a normal expectation for Crohn's biologics, and drugmakers began competing on delivery devices as much as on efficacy.

Why this matters now

Skyrizi's on-body injector repeats that move from clinic to home, this time for a drug that has been infusion-only in Crohn's since launch.

March 2025

Tremfya's subcutaneous Crohn's approval (2025)

Johnson & Johnson won U.S. approval for guselkumab in Crohn's disease with both subcutaneous and intravenous induction, roughly 19 months before Skyrizi's subcutaneous option.

Then

Prescribers gained a home-injection induction option from a competing IL-23 inhibitor.

Now

The approval set the expectation that new Crohn's biologics would offer a self-administered start, putting infusion-only labels at a commercial disadvantage.

Why this matters now

This approval closes a competitive gap rather than opening a new one. The mechanism is parity, not novelty.

2022

Skyrizi's original Crohn's approval (2022)

Risankizumab was approved for moderately to severely active Crohn's disease and launched with intravenous induction at weeks 0, 4 and 8, followed by subcutaneous maintenance.

Then

Patients had to arrange clinic visits for their first three doses before switching to at-home maintenance injections.

Now

Induction stayed the one part of the treatment course that required a health care setting, until this label change.

Why this matters now

The new regimen removes the last clinic-dependent step from the standard Skyrizi course.