Listen to this article

The basics:

• FDA approves Johnson & Johnson‘s Icotyde for moderate-to-severe plaque psoriasis
• Once-daily pill is first oral IL-23 treatment option for eligible patients
• Clinical trial showed about 74% of participants had clear or nearly clear skin by week 24
• Drug could compete with injectable treatments such as Tremfya, Skyrizi

New Brunswick-based Johnson & Johnson has secured U.S. Food and Drug Administration approval for its once-daily plaque psoriasis pill.

As the first oral option greenlit by regulators, Icotyde offers a more convenient option for patients. The chronic autoimmune condition causes inflamed patches of skin.

The March 18 approval covers the use of the drug for moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age or older who weigh at least 88 pounds.

Plaque psoriasis (PsO) affects an estimated 8 million Americans and more than 125 million people worldwide. It can also take a toll beyond the skin, affecting emotional well-being, social life and daily routines.

Patients usually start with topical treatments and move to pills or injections if needed, though many avoid shots due to needle fear, according to J&J.

The company believes Icotyde has the potential to become the first-line systematic treatment for psoriasis in between topicals and shots.

Potential cost savings

It also gives patients an oral alternative to some of the most advanced – and expensive – drugs on the market. Best-selling shots such as J&J’s Tremfya and AbbVie’s Skyrizi cost about $100,000 a year, CNBC noted.

J&J has not issued further details on pricing or availability for Icotyde. However, the pharmaceutical giant said it is “committed to helping patients access our treatments” and will offer cost support options.

It developed the therapy in partnership with California-headquartered biopharmaceutical company Protagonist Therapeutics. Icotyde targets the same IL-23 receptor as Tremfya and Skyrizi.

The FDA’s approval is based on evidence from a phase three clinical trial that found Icotyde was a safe and effective oral pill for adults and teens with moderate-to-severe plaque psoriasis. About 74% of the 2,500 participants achieved clear or nearly clear skin by week 24.

‘A pivotal moment’

John Reed is executive vice president of R&D and innovative medicine for J&J. He described the approval as “a pivotal moment for people with plaque psoriasis.”

“At Johnson & Johnson, we are harnessing our scientific expertise to transform cutting-edge science into meaningful solutions for patients. Icotyde is a fundamentally different treatment with the potential to redefine what physicians and patients can expect from psoriasis treatment,” Reed said.

Icotyde is a fundamentally different treatment with the potential to redefine what physicians and patients can expect from psoriasis treatment.
– John Reed, Johnson & Johnson executive vice president of R&D and innovative medicine

J&J Executive Vice President and Worldwide Chair of Innovative Medicine Jennifer Taubert added, “We’re proud to bring this game-changing innovation to the market, marking a transformative shift in plaque psoriasis management that empowers patients and clinicians to reach their treatment goals.”

Wall Street analysts see Icotyde as having “blockbuster potential,” with the oral pill expected to capture market share from injectables like Skyrizi and Tremfya, Reuters reported.

J&J is also testing it for psoriatic arthritis, ulcerative colitis and Crohn’s disease. The company projects peak annual sales could exceed $5 billion if approved for these additional conditions, according to CNBC.