FDA Approves J&J's Icotyde, First Oral Psoriasis Pill to Challenge Injectables Tremfya and Skyrizi
The FDA has approved Icotyde, Johnson & Johnson's oral pill for moderate to severe plaque psoriasis, representing the first oral option to rival IL-23 inhibitor injectables like Tremfya and Skyrizi. This approval addresses a key patient need, as many individuals avoid injections due to needle aversion. While Icotyde's pricing remains undisclosed, competing injectables cost approximately $100,000 annually, and J&J anticipates peak sales over $5 billion if expanded to other conditions. The announcement affected stock prices, with AbbVie declining more sharply than J&J. Icotyde is also being studied for additional autoimmune disorders, which could broaden its therapeutic application.
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The U.S. Food and Drug Administration has approved Icotyde, Johnson & Johnson's once-daily oral pill for moderate to severe plaque psoriasis, marking the first oral treatment to directly compete with blockbuster injectable drugs like Tremfya and Skyrizi.
Drug Overview and Mechanism
Icotyde targets the IL-23 receptor, the same biological pathway as J&J's Tremfya and AbbVie's Skyrizi. It is approved for adults with plaque psoriasis, an autoimmune condition causing red, scaly skin patches. Johnson & Johnson positions Icotyde as a first-line systematic treatment, intended for use after topical therapies but before injectables.
Patient Impact and Market Position
Approximately 8 million Americans are affected by plaque psoriasis.
J&J estimates that 75% of patients do not progress from topical treatments to injectables due to barriers like needle phobia.
Icotyde provides an oral alternative that could capture this underserved patient segment, offering convenience and potentially higher adherence.
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Pricing and Financial Outlook
Johnson & Johnson has not disclosed the pricing for Icotyde.
Competing injectables, such as Tremfya and Skyrizi, have an annual cost of around $100,000.
J&J projects peak annual sales exceeding $5 billion if Icotyde receives approvals for additional autoimmune conditions.
Stock Market Reaction
Johnson & Johnson's shares declined by 0.25% following the approval announcement.
AbbVie, the maker of Skyrizi, experienced a stock drop of over 4%.
Protagonist Therapeutics, the biotech company that co-developed Icotyde with J&J, saw minimal trading movement.
Ongoing Research and Future Indications
Icotyde is currently in clinical trials for other autoimmune diseases, including:
