Signage outside the Johnson & Johnson offices in Irvine, California, United States, Friday, October 10, 2025.
Kyle Grillot | Bloomberg | Getty Images
Johnson & Johnson said Wednesday that the U.S. Food and Drug Administration has approved its once-daily psoriasis pill, the first oral option to rival the best-selling injections.
The FDA approved the pill, Icotyde, to treat moderate to severe plaque psoriasis, an autoimmune disease that causes roughness on the skin. Patients usually begin treatment with topical medications.
If these don’t work, they move on to pills or injections. J&J sees Icotyde becoming the first-line systematic treatment for psoriasis, between topicals and injections.
Drug manufacturers have developed medications that are more advanced than standard topical medications, making psoriasis a highly competitive field. Icotyde targets the same IL-23 receptor as top-selling injections like J&J’s Tremfya and AbbVieSkyrizi, offering patients an oral alternative to some of the most advanced – and expensive – medications on the market.
“Being able to have something that is relatively simple, that provides this level of authorization, a reliable safety profile and in a simple pill, we think it’s going to be revolutionary,” said Jennifer Taubert, president of J&J Innovative Medicine.
J&J estimates that about 8 million people in the United States have plaque psoriasis, and 75 percent of them don’t switch from topical treatments to injections for reasons such as fear of needles. Taubert sees Icotyde attractive for these patients.
“We think with the type of profile that Icotyde has in a simple once-daily oral pill, we think it’s going to be a game-changer for patients,” Taubert said.
J&J did not announce how much Icotyde would cost, only saying the company would help people pay for the drug. Rival shots Tremfya and Skyrizi cost around $100,000 a year.
J&J expects peak annual sales of Icotyde to exceed $5 billion once approved for other autoimmune diseases. The drug is currently being tested against psoriatic arthritis, ulcerative colitis and Crohn’s disease.
Shares of J&J fell a quarter of a percent on Wednesday, while shares of Skyrizi maker AbbVie fell more than 4%. Therapeutic protagonista biotech company that developed Icotyde with J&J, was trading roughly flat.