Risankizumab-RZAA

Johnson & Johnson secured an FDA approval on Wednesday for a psoriasis pill it expects to become a megablockbuster. Regulators gave the green light to icotrokinra, which will be branded as Icotyde, in patients 12 and older with moderate-to-severe plaque psoriasis. There was no immediate information on pricing, but J&J expects peak sales to surpass $5 billion annually if it gets approved in other immunologic diseases. As a once-daily oral option, Icotyde is expected to compete with established psoriasis drugs not just on efficacy but also convenience. Both Icotyde and AbbVie’s Skyrizi — the runaway market leader with more than $17 billion in sales last year — target IL-23. But Skyrizi is an injectable drug, given every 12 weeks. J&J’s Tremfya is also a psoriasis injectable. Icotyde has also shown effectiveness compared to Bristol Myers Squibb’s Sotyktu, another once-daily psoriasis pill targeting TYK2. Last September, J&J said its drug beat Sotyktu in two Phase 3 studies. Researchers are also testing Icotyde against another J&J drug, Stelara, an injectable that targets both IL-12 and IL-23. But J&J and its biotech partner Protagonist Therapeutics have work to do outside psoriasis to reach that $5 billion figure, most notably in inflammatory bowel diseases like ulcerative colitis and Crohn’s. Early results have been promising, with Icotyde succeeding in a Phase 2b UC study last year. The approval represents the first commercial product for Protagonist, though J&J will handle the launch and sales. Protagonist will get a $50 million milestone payment for the decision and can get up to another $580 million in biobucks, as well as royalty payments on sales between 6% and 10%. The FDA is expected to decide whether to approve another of Protagonist’s drugs, rusfertide — a rare blood disorder program partnered with Takeda — by August.

The US FDA has approved Icotyde (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients aged 12 years and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy. The approval, announced by Johnson & Johnson (J&J), marks the first oral peptide to target the interleukin-23 (IL-23) receptor to reach the market. The drug was jointly discovered by Protagonist Therapeutics and Janssen Biotech under a license and collaboration agreement first established in 2017 and subsequently expanded. J&J holds worldwide rights to develop and commercialize the compound. Icotyde is administered as a once-daily 200 mg oral tablet taken on an empty stomach. The approved indication covers patients who are candidates for systemic therapy or phototherapy, positioning it as a first-line systemic option. The prescribing information notes infection risk as the primary safety concern, consistent with other agents that modulate IL-23 signaling, and advises screening for tuberculosis prior to treatment initiation. The label also includes a pediatric indication from launch, covering adolescents aged 12 and older at or above 40 kg, a population not covered by the only other oral systemic approved in this space, Bristol Myers Squibb’s deucravacitinib (Sotyktu). The approval rests on four Phase III studies from the ICONIC clinical development program, which enrolled approximately 2,500 patients. Two of these, ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, were duplicate head-to-head trials comparing icotrokinra with both placebo and deucravacitinib. At Week 16, approximately 70% of icotrokinra-treated patients achieved clear or almost clear skin as measured by IGA 0/1, and 55% achieved PASI 90. The ICONIC-LEAD trial evaluated efficacy and safety against placebo in adults and adolescents, while ICONIC-TOTAL assessed outcomes in patients with psoriasis affecting high-impact sites including scalp, genital, and palmoplantar areas. Across the program, adverse reaction rates in icotrokinra-treated patients were within 1.1% of placebo through Week 16, the company said, and no new safety signals emerged through Week 52. The approval enters a treatment landscape already populated by injectable IL-23 inhibitors such as guselkumab and risankizumab, IL-17 inhibitors including secukinumab and ixekizumab, and the dual IL-17A/F inhibitor bimekizumab, approved in 2023. Deucravacitinib, a selective TYK2 inhibitor approved in September 2022, was the first oral targeted therapy in this space but acts through a distinct mechanism. Icotyde is differentiated by its modality — an orally bioavailable peptide that binds the IL-23 receptor and inhibits downstream signaling — rather than targeting the cytokine itself or upstream kinases. The head-to-head design against deucravacitinib in the ICONIC-ADVANCE studies provides direct comparative data that may inform treatment sequencing, though full publications of these results are awaited. The label also includes a pediatric indication from launch, covering adolescents aged 12 and older weighing at least 40 kg. Unlike Bristol Myers Squibb’s deucravacitinib, which is approved only in adults for plaque psoriasis, icotrokinra enters the market with adolescent labeling; however, apremilast is already approved as an oral systemic option for pediatric plaque psoriasis in younger patients. The pipeline behind Icotyde remains active: J&J continues to study the molecule in psoriatic arthritis, ulcerative colitis, and Crohn’s disease. Also under development are next-generation TYK2 inhibitors from Takeda and Alumis, both in Phase III, and oral IL-17A inhibitors in earlier development. Psoriasis affects an estimated 8 million Americans, and nearly 25% of cases are classified as moderate-to-severe. For patients who cycle through topical therapies without adequate control, the availability of an oral agent targeting the IL-23 receptor adds a mechanistically distinct systemic option to existing injectable and oral alternatives. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website