FDA approves psoriasis pill from J&J that rivals shots Tremfya, Skyrizi

Johnson & Johnson on Wednesday said the U.S. Food and Drug Administration approved its once-daily psoriasis pill, the first oral option to rival best-selling shots.

The FDA approved the pill, Icotyde, to treat moderate to severe plaque psoriasis, an autoimmune condition that causes rough patches of skin. Patients typically start treatment with topical medications.

If those don't work, they advance to pills or shots. J&J sees Icotyde becoming the first-line systematic treatment for psoriasis, in between topicals and shots.

Drugmakers have been developing more advanced medicines than standard topicals, turning psoriasis into a highly competitive space. Icotyde targets the same IL-23 receptor as best-selling shots like J&J's Tremfya and AbbVie's Skyrizi, giving patients an oral alternative to some of the most advanced — and most expensive — drugs on the market.

"To be able to to be able to have something that is relatively simple, that offers that level of clearance, trusted safety profile, and in a simple pill, we think is going to be revolutionary," said Jennifer Taubert, chairman of J&J Innovative Medicine.

J&J estimates about 8 million people in the U.S. have plaque psoriasis, and that 75% of people don't advance from topicals to shots because of reasons like fearing needles. Taubert sees Icotyde appealing to those patients.

"We believe having the type of profile that Icotyde has in a simple, once-daily oral pill, we think it's going to be an absolute game changer for patients," Taubert said.

J&J hasn't announced how much Icotyde will cost beyond saying the company will help people pay for the medicine. Rival shots Tremfya and Skyrizi cost around $100,000 a year.

J&J sees peak annual sales of Icotyde exceeding $5 billion once it's approved for other autoimmune conditions. It's testing the drug for psoriatic arthritis, ulcerative colitis and Crohn's disease.

Shares of J&J slid one-quarter of a percent Wednesday while shares of Skyrizi-maker AbbVie fell more than 4%. Protagonist Therapeutics, a biotech company that developed Icotyde with J&J, was trading about flat.