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FDA approval · Johnson & Johnson · Dermatology

Icotydeicotrokinra

The first oral peptide that blocks the IL-23 receptor, approved for plaque psoriasis.

CompareJohnson & Johnson press release
FDA approval · New moleculeFirst oral peptide to block the IL-23 receptor60-second read

Icotydeicotrokinra

Johnson & Johnson · IL-23 receptor antagonist (oral peptide) · Dermatology

Bottom line for your patients

Patients aged 12 and older with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy have a once-daily pill that blocks the IL-23 receptor. In the head-to-head Phase 3 studies, approximately 70% of patients reached clear or almost clear skin at Week 16.

Drug brief
Drug IQ
Who it is for
Adults and pediatric patients 12 years of age and older who weigh at least 40 kg, with moderate-to-severe plaque psoriasis, who are candidates for systemic therapy or phototherapy.
What changes
The ICONIC-ADVANCE 1 and 2 trials compared Icotyde with both placebo and deucravacitinib in adults, and Johnson & Johnson describes them as head-to-head superiority studies. The release does not report the response rates in the deucravacitinib or placebo arms.
The evidence
In the head-to-head superiority studies, approximately 70% of patients achieved clear or almost clear skin (IGA 0/1) and 55% achieved a PASI 90 response at Week 16. Icotyde met all primary efficacy endpoints across four Phase 3 studies.Head-to-head randomized trialICONIC-ADVANCE 1 and 2, ICONIC-LEAD, ICONIC-TOTAL · Phase 3 · 2,500 participantsRandomized against an active treatment: the most direct evidence on how it compares with an existing option.
Watch for
Safety information warns of an increased risk of infections, with checks for infection and tuberculosis before treatment, and says to avoid live vaccines during treatment. The most common side effects are headache, nausea, cough, fungal infection and tiredness; rates of adverse reactions were within 1.1% of placebo through Week 16, with no new safety signals through Week 52.
How it is given
OralOne pill (200 mg) once a day with water upon waking, 30 minutes before eating food.
What the approval tells you
New molecule. An active ingredient the FDA had not approved before.

Clinical summary

A once-daily oral IL-23 receptor antagonist for moderate-to-severe plaque psoriasis in adults and in children 12 and older weighing at least 40 kg who are candidates for systemic therapy or phototherapy. In the head-to-head ICONIC-ADVANCE 1 and 2 trials against deucravacitinib, about 70% of patients reached IGA 0/1 and 55% reached PASI 90 at week 16. It is taken on an empty stomach, at least 30 minutes before eating.

From the source 10

Johnson & Johnson press release

The Johnson & Johnson press release's own words, quoted exactly. Each line is what a claim on this page was checked against.

  1. Johnson & Johnson (NYSE: JNJ) announced today that the U.S. Food and Drug Administration (FDA) has approved ICOTYDE™ (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy.

    Backs · Approved indication and population (12 years and older, at least 40 kg); IL-23 receptor antagonist

  2. ICOTYDE is the first and only targeted oral peptide that precisely blocks the IL-23 receptor.

    Backs · First and only targeted oral peptide that blocks the IL-23 receptor

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

    Backs · Four Phase 3 studies, 2,500 patients, all primary endpoints met

View all 10 lines

  1. In the head-to-head superiority studies, approximately 70% of patients achieved clear or almost clear skin (IGA 0/1) and 55% of patients achieved a Psoriasis Area and Severity Index (PASI) 90 response at Week 16.

    Backs · Approximately 70% IGA 0/1 and 55% PASI 90 at Week 16 in head-to-head superiority studies

  2. Rates of adverse reactions for ICOTYDE treated patients were within 1.1% of placebo through Week 16 and no new safety signals were identified through Week 52.

    Backs · Adverse reactions within 1.1% of placebo through Week 16; no new safety signals through Week 52

  3. ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604) are RCTs to evaluate the efficacy and safety of ICOTYDE compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque PsO.

    Backs · ICONIC-ADVANCE 1 and 2 compared with placebo and deucravacitinib

  4. Patients on ICOTYDE take one pill, once a day with water upon waking, 30 minutes prior to eating food.

    Backs · Dosing: one pill once a day on waking, 30 minutes before food

  5. ICOTYDE 200 mg is a prescription medicine used to treat moderate to severe plaque psoriasis in adults and children 12 years of age and older who weigh at least 88 pounds (40 kg), who may benefit from taking injections or medicines by mouth (systemic therapy) or treatment using ultraviolet or UV light (phototherapy).

    Backs · 200 mg

  6. Avoid receiving live vaccines during treatment with ICOTYDE.

    Backs · Live vaccines should be avoided

  7. Medicines that interact with the immune system, such as ICOTYDE, may lower your ability to fight infections and may increase your risk of infections.

    Backs · Infection risk

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