On Wednesday, the U.S. Food and Drug Administration (FDA) approved Icotyde (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older.

FDA Approves Icotyde for Plaque Psoriasis in Adults and Teens

Icotyde was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist Therapeutics, Inc. ( PTGX ) and Johnson & Johnson ( JNJ ) .

Johnson & Johnson ( JNJ ) retains exclusive worldwide rights to develop Icotyde in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications.

FDA approval of Icotyde triggers a $50 million milestone payment to Protagonist, and it is eligible to receive up to $580 million in potential additional regulatory and sales milestone payments, as well as tiered sales-based royalties.

Johnson & Johnson ( JNJ ) introduces the first and only IL-23R targeted oral peptide that delivers complete skin clearance and a favorable safety profile in a once-daily pill.

Phase 3 Data Highlights Strong Efficacy and Safety Profile

Icotyde met all primary endpoints and demonstrated a favorable safety profile across four Phase 3 studies, including 2,500 patients.

The approval is based on data from the ICONIC clinical development program, which simultaneously evaluated Icotyde in adults and adolescents, high-impact sites such as scalp and genital PsO, and in duplicate head-to-head trials versus an active comparator.

AbbVie Stock Slips as Icotyde Raises Competitive Concerns

In reaction to the FDA approval, AbbVie Inc ( ABBV ) stock fell.

BNP Paribas Equity Research on Wednesday wrote that Icotyde approval may represent competition to AbbVie's ( ABBV ) Skyrizi (risankizumab-rzaa).

Analyst Navann Ty expects Skyrizi to remain well-positioned in plaque psoriasis with the strong efficacy, and the quarterly subcutaneous administration of Skyrizi (after the induction period) also provides compliance benefits.

Oral Therapies Could Expand Psoriasis Market Opportunity

Both companies have indicated that the entry of an oral could help to expand the market, providing more access and increasing penetration from the current 30-40%, implying Skyrizi should still have room to grow.

Icotyde is also being studied in active psoriatic arthritis, moderately-to-severely active ulcerative colitis, and moderately-to-severely active Crohn’s disease.

The additional studies could represent additional competition to Skyrizi. BNP Paribas forecasts Skyrizi growing 23% in fiscal 2026 with an FY25-28E CAGR of 14%, representing a key growth driver for AbbVie ( ABBV ).

ABBV Stock Price Activity: AbbVie ( ABBV ) shares closed 5.20% lower at $208.34 on Thursday, according to Benzinga Pro data.

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