J&J wins FDA nod for psoriasis pill that aims to compete with top-selling injections

Dive Brief:

Johnson & Johnson said Wednesday it won Food and Drug Administration approval to sell what it calls a “game-changing” pill to treat psoriasis.
The drug is part of a class of medicines that work by blocking the action of a protein called IL-23, a key player in the body’s inflammatory response. It’s an approach that has proved extremely effective, spurring a generation of blockbuster injectable medicines including AbbVie’s Skyrizi and J&J’s own Tremfya.
J&J’s new entry is the first in the class that can be taken orally, offering patients the convenience of a once-daily pill. The drug, icotrokinra, will be sold as Icotyde and is available to treat moderate-to-severe plaque psoriasis in patients over the age of 12 who weigh at least 40 kilograms, or 88 pounds.

Dive Insight:

Icotyde will compete both with existing IL-23 injectable medicines and a growing group of oral options that work in different ways to tackle autoimmune conditions. Companies like Takeda Pharmaceutical are working on drugs that block a protein called TYK2, and the FDA has already approved one: Bristol Myers Squibb’s Sotyktu.

Eli Lilly, meanwhile, paid billions a few years ago to acquire an IL-17 blocker.

Companies are continuing to look at ways to improve on IL-23 targeting drugs as well. AbbVie last year scooped up privately held Nimble Therapeutics and absorbed a pipeline of oral peptide drugs that includes one targeted at IL-23. Sanofi, meanwhile, agreed to pay $125 million to startup Earendil Labs to gain two bispecific antibodies, one of which aims at IL-23 along with another target.

J&J has said Icotyde has the potential to top $5 billion in sales. It gained the rights to the drug through a collaboration with Protagonist Therapeutics, which will receive a $50 million milestone payment based on the FDA approval. Protagonist is also eligible for royalties on sales and stands to rake in as much as $580 million more for reaching additional regulatory and commercial milestones.

About 8 million Americans and some 125 million people around the world have psoriasis, according to the National Psoriasis Foundation. Most of that group has a form called plaque psoriasis, which causes inflamed, scaly plaques on the skin that can be itchy and painful. Doctors usually try topical treatments first, then consider systemic therapies like those that target IL-23.

Icotyde won approval after succeeding in four Phase 3 studies that included 2,500 patients, J&J said. Data from two trials first released in 2024, dubbed ICONIC-LEAD and ICONIC-TOTAL, showed that patients taking Icotyde had significantly clearer skin than those on placebos. Two other studies published last year, ICONIC-ADVANCE 1 and 2, found a benefit for Icotyde over Sotyktu.

Overall, the company’s development in psoriasis includes five late-stage trials: two that compare Icotyde with a placebo, two that include a comparator arm with Sotyktu and one that includes a comparator arm with Stelara, an older injectable sold by J&J. The company is also studying the medicine’s effects in other diseases including psoriatic arthritis, ulcerative colitis and Crohn’s disease.