Peptide News Digest

#European-Commission-Approval

2 stories

Regulatory · View digest

European Commission Approves Johnson & Johnson's ICOTYDE (Icotrokinra), an Oral Peptide IL-23 Receptor Antagonist, for Moderate-to-Severe Plaque Psoriasis in Adults and Adolescents

Johnson & Johnson announced on Monday, September 21, 2026 that the European Commission granted marketing authorization for ICOTYDE (icotrokinra) for adults and adolescents aged 12 and older weighing at least 40 kg with moderate-to-severe plaque psoriasis who are candidates for systemic therapy. J&J calls icotrokinra the first targeted oral peptide that precisely blocks the IL-23 receptor; it was jointly discovered and is being developed under J&J's license and collaboration agreement with Protagonist Therapeutics. The approval rests on the ICONIC program of four Phase 3 studies in about 2,500 patients (ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1 and 2). In the head-to-head studies, about 70% of patients on icotrokinra reached clear or almost clear skin (IGA 0/1) and 55% reached PASI 90 at week 16. Patients take one pill once daily with water on waking, at least 30 minutes before eating.

Regulatory · View digest

NewAmsterdam Pharma and Menarini Receive First Obicetrapib Approval Worldwide: European Commission Approves Ubeslo and Evlarco for Primary Hypercholesterolemia

NewAmsterdam Pharma and Menarini Group announced on Monday, September 21, 2026 that the European Commission approved Ubeslo (obicetrapib 10 mg) and Evlarco (obicetrapib 10 mg plus ezetimibe 10 mg) for adults with primary hypercholesterolemia, including heterozygous familial and non-familial forms, or mixed dyslipidemia. The companies called it the first regulatory approval of obicetrapib, an oral, low-dose CETP inhibitor, anywhere in the world. The approval cites the Phase 3 BROADWAY, BROOKLYN, and TANDEM trials, which showed LDL-C reductions of up to 40% with obicetrapib alone and about 50% with the ezetimibe combination versus placebo, with tolerability comparable to placebo. Menarini holds exclusive European commercialization rights and pays NewAmsterdam tiered double-digit royalties, with up to €833 million more in milestones.