Johnson & Johnson’s (J&J) Icotyde (icotrokinra) has been approved by the US FDA to treat moderate-to-severe plaque psoriasis (PsO) in both adults and paediatric patients.
Icotyde, an interleukin-23 (IL-23) receptor antagonist, is the first and only targeted oral peptide that precisely blocks the IL-23 receptor. It’s been approved for adults and paediatric patients over the age of 12 who weigh at least 40kg and who are candidates for systemic therapy or phototherapy.
In four phase 3 studies, the ICONIC clinical development programme, Icotyde met all its primary efficacy points and presented with a favourable safety profile.
Linda Stein Gold, Director of Dermatology Clinical Research at Henry Ford Health, said: “Icotyde delivers something unique in psoriasis treatment – combining skin clearance with a favourable safety profile in a once-daily pill, making it an easy addition to a patient’s routine.”
Forming the basis for the approval, the ICONIC trials involved 2,500 patients and evaluated Icotyde in both adolescents and adults in high impact sites like scalp and genital PsO.
When tested in head-to head superiority trials versus an active comparator, approximately 70% of patients achieved clear or almost clear skin and 55% of patients achieved a Psoriasis Area and Severity Index (PASI) 90 response at week 16.
Jennifer Taubert, Executive Vice President, Worldwide Chairman, Innovative Medicine, Johnson & Johnson, said: “This…marks a transformative shift in plaque psoriasis management that empowers patients and clinicians to reach their treatment goals.”
PsO is a chronic immune-mediated disease causing inflamed, scaly plaques that can be itchy or painful, with nearly a quarter of those with the affected having cases considered moderate-to-severe.
Affecting more than eight million people in the US and over 125 million worldwide, psoriasis can impact quality of life.
Leah Howard, President and CEO of the National Psoriasis Foundation, said: “Finding the right treatment can take time, during which people with psoriatic disease should be considering multiple factors from efficacy to safety to how the treatment fits into their everyday life.
“The approval of a novel systemic therapy changes the conversation about treatment options for our community.”