FDA drops TB test requirement for Skyrizi after NPF guidance

The U.S. Food and Drug Administration no longer requires tuberculosis testing before people start risankizumab, sold as Skyrizi, unless a clinician decides it is needed. The change follows medical guidance aimed at removing access barriers for people with psoriatic and other immune-mediated diseases.

Why it matters: - The FDA change removes a step that could delay treatment for people with psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. - The decision may also reduce costs, appointment burden and false-positive TB test results before patients can start therapy. - The update gives prescribing clinicians more discretion to decide when TB testing is medically necessary.

What happened: - The FDA removed the tuberculosis testing requirement from the label for risankizumab, sold as Skyrizi. - The drug is used to treat psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis. - The change means people no longer need a TB test before starting risankizumab unless a healthcare professional decides one is needed. - The National Psoriasis Foundation said the change follows last week’s FDA action.

The details: - In 2025, the National Psoriasis Foundation Medical Board and the International Psoriasis Council said latent TB testing for IL-17 and IL-23 inhibitors was an unnecessary barrier for people with psoriatic disease. - After that guidance, the FDA did not require TB testing for Johnson & Johnson’s oral treatment icotrokinra, sold as Icotyde. - The updated risankizumab label gives people with chronic inflammatory diseases one less obstacle before starting or resuming treatment with Skyrizi or Icotyde. - Leah M. Howard, president and CEO of the National Psoriasis Foundation, said the change reflects nonprofit, government and pharmaceutical leadership working together to reduce barriers to care. - Howard said the NPF Medical Board and IPC made a case for discontinuing TB testing requirements on these IL-17 and IL-23 drugs. - Guy Eakin, chief scientific and medical officer of the National Psoriasis Foundation, said TB testing can add cost, take clinician and patient time, and create false positives. - Eakin said the change allows healthcare professionals to make informed decisions about when, or whether, to test for TB. - The National Psoriasis Foundation Medical Board evaluates emerging data, publishes findings and sets best practices on policy, research and treatment. - In 2025, the board also issued a position statement on how psoriasis severity is best assessed. - The board also established a consensus-based definition of on-treatment remission for plaque psoriasis.

Between the lines: - The FDA move suggests regulators are increasingly willing to defer to disease experts on whether blanket TB screening is necessary for certain immune-targeting drugs. - The decision also reinforces the influence of specialty nonprofit guidance when it is backed by published expert consensus. - The National Psoriasis Foundation is pushing a broader access argument: fewer routine hurdles may help patients start effective treatment sooner.

What's next: - The National Psoriasis Foundation said it hopes the same approach will extend to other drugs with similar mechanisms of action. - Clinicians will now decide case by case whether TB testing is needed before starting risankizumab. - The National Psoriasis Foundation said it will continue publishing guidance aimed at improving care for people with psoriatic disease.

The bottom line: - The FDA’s risankizumab label change cuts another pre-treatment barrier for patients and shifts more decision-making to clinicians.