US FDA approves J&J's oral psoriasis pill

By Sriparna Roy

March 18 (Reuters) - The ‌U.S. Food ​and Drug ​Administration has approved Johnson & Johnson's oral pill for psoriasis, the company said on Wednesday, paving the way for a more convenient ‌treatment option for patients with the chronic autoimmune condition that causes ⁠itchy, scaly, and inflamed patches of skin.

The health regulator approved the drug for moderate-to-severe plaque psoriasis ‌in adults and children 12 ‌years of age and older who weigh at least 40 kg.

The company did not respond to a Reuters request for comment on pricing and ​availability.

The first-of-its-kind oral drug, branded as Icotyde, will help the drugmaker expand into the psoriasis market and compete with treatments such as Bristol Myers Squibb's ⁠Sotyktu and AbbVie's Skyrizi.

Wall Street analysts have said Icotyde has "blockbuster potential" as a safe and effective oral, ​and that the once-daily medication could capture significant market share from injectables like Skyrizi and J&J's own Tremfya.

"The key now will ​be Icotyde's commercial uptake, which we think ‌will be quite rapid given its clinical profile as a potential best oral option for patients with psoriasis," said Guggenheim ⁠analyst Vamil Divan.

Divan estimates that Icotyde could generate more than $8 billion in annual peak sales.

The drug has shown superior skin clearance compared with Bristol's Sotyktu in two late-stage, head-to-head ⁠trials.

Patients have been looking for complete skin clearance, a favorable safety profile, and the simplicity ​of a once-a-day pill, David Lee, J&J's global head of immunology, told Reuters ahead of the decision.

"We see Icotyde as becoming the first-line systemic therapy for psoriasis patients," said Lee.

J&J's ‌oral pill is designed to block a protein, IL-23, involved in inflammatory responses. The oral drug is developed in ‌partnership with Protagonist Therapeutics.

J&J is also studying the drug, chemically known as icotrokinra, for ⁠ulcerative colitis, psoriatic arthritis and Crohn's ‌disease.

The company expects Icotyde ​to exceed $5 billion in peak annual sales across indications.

(Reporting by Sriparna Roy in Bengaluru; Editing by Alan Barona, Shinjini Ganguli and ‌Devika Syamnath)

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