U.S. FDA Drops TB Testing Requirement for Skyrizi®, Following NPF Medical Board Guidance

People no longer need a TB test before starting risankizumab (Skyrizi®), unless their healthcare professional decides one is needed.

ALEXANDRIA, VA, UNITED STATES, October 26, 2026 /EINPresswire.com/ — There is one less barrier to care for people living with a range of immune-mediated and autoimmune diseases, thanks to the leadership of the National Psoriasis Foundation (NPF) Medical Board. Last week, the U.S. Food and Drug Administration (FDA) removed the tuberculosis (TB) testing requirement for the widely used drug risankizumab (Skyrizi), which is indicated for the treatment of psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

In 2025, the NPF Medical Board and the International Psoriasis Council (IPC) identified latent TB testing for IL-17 and IL-23 inhibitors as an unnecessary barrier between people with psoriatic disease and the medications their doctors prescribe. Following that published expert guidance, the FDA did not require TB testing for Johnson & Johnson’s new oral treatment icotrokinra (Icotyde). With the updated label for risankizumab, even more people with chronic inflammatory diseases now have one less obstacle to overcome before starting or resuming treatment with Skyrizi or Icotyde.

“This is a great example of nonprofit, government, and pharmaceutical leadership working together to reduce barriers between people living with chronic disease and the treatments they rely on to live their healthiest lives,” said Leah M. Howard, J.D., President and CEO of NPF. “The NPF Medical Board and IPC used patient-first thinking to make a strong case for discontinuing TB testing requirements on these IL-17 and IL-23 drugs, and now people with a number of diseases will have easier access. We hope to see this domino effect continue with other drugs that share a similar mechanism of action.”

By leaving the decision about latent TB testing to the prescribing healthcare professional, the FDA allows those with medical expertise and knowledge of their patients to make informed decisions about when, or whether, to test for TB.

“A TB test is not just a simple test. It is a cost to the patient. It is the clinician’s and patient’s time, and there are risks of false positives. In short – it is yet another hurdle people must clear simply to access the modern treatments available today for psoriatic disease,” said Guy Eakin, Ph.D., Chief Scientific and Medical Officer of NPF. “I’m proud of our Medical Board’s leadership and its collaboration with the International Psoriasis Council. Together, we’re empowering healthcare professionals to make the right decisions for their patients. This is proof that when we keep patient interests and well-being at the forefront of our decision-making, we can create new ways to improve access to effective care and remove unnecessary burdens.”

The NPF Medical Board issues expert guidance and insight to improve the standard of care for people living with psoriatic disease. The board does so by evaluating emerging data, publishing findings, and establishing best practices related to policy, research, and treatment. In 2025, in addition to the joint TB testing statement with IPC, the NPF Medical Board issued a position statement clarifying how psoriasis severity is best assessed. It also established a consensus-based definition of on-treatment remission for plaque psoriasis, a major milestone on the journey toward a cure for psoriatic disease.

About The National Psoriasis Foundation

NPF is the largest nonprofit funder of psoriatic disease research in the world and the leading organization representing individuals with psoriasis and psoriatic arthritis. The mission of NPF is to drive efforts to cure psoriatic disease and improve the lives of more than 8 million individuals in the United States affected by this chronic immune-mediated disease. Learn more at psoriasis.org.

Matt Werbach
National Psoriasis Foundation

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