Johnson and Johnson Gets USFDA Nod for Oral Psoriasis Drug Icotyde

The health regulator approved the drug ​for moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 ​kg. The company did not immediately respond ⁠to Reuters' ‌requests for comment on pricing and availability.

The drug, ​branded as ​Icotyde, will compete with Bristol Myers Squibb's Sotyktu ⁠and AbbVie's Skyrizi. Wall Street analysts have said ​J&J's Icotyde has "blockbuster potential" as a safe ​and effective oral, and that the once-daily medication could capture significant market share.

The drug has shown superior skin clearance compared to 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, like AbbVie's Skyrizi and J&J's own Tremfya, 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.