FDA approves icotrokinra, first oral peptide for adults and teens with plaque psoriasis

FDA approves icotrokinra, first oral peptide for adults and teens with plaque psoriasis

Key takeaways:

• The FDA approved Icotyde for adults and adolescents aged 12 years and older with moderate to severe plaque psoriasis.
• It is the first targeted oral peptide in this indication that blocks IL-23.

The FDA approved icotrokinra for adults and adolescents aged 12 years and older with moderate to severe plaque psoriasis, Johnson & Johnson announced in a press release.

Icotrokinra (Icotyde) is the first and only targeted oral peptide that blocks the interleukin-23 receptor. Adolescents must weigh at least 40 kg and be candidates for systemic therapy or phototherapy, according to the release.

“Moderate to severe plaque psoriasis has historically had limited oral treatment options that effectively balance efficacy with acceptable safety and tolerability,” Linda Stein Gold, MD, director of dermatology clinical research at Henry Ford Health, told Healio. “This therapy offers patients an additional oral option with clinical data suggesting meaningful efficacy and a favorable safety and tolerability profile.”

Clarifying guidance from the International Psoriasis Council on when to transition from cycling topical treatments to systemic therapy has created an environment for icotrokinra to be a “game-changer” for many adults and adolescents with plaque psoriasis, Stein Gold said.

The International Psoriasis Council’s guidance states that patients should transition to systemic therapy if two cycles of topical medications applied for 4 weeks fail to bring meaningful improvement, according to the release.

The approval was supported by four phase 3 studies comprising a total of 2,500 patients. In the ICONIC clinical development program, positive data supported icotrokinra’s use for treating high-impact psoriasis sites, including the scalp and genitals, in adults and adolescents. Head-to-head superiority studies showed approximately 70% of patients reached IGA clear or almost clear and 55% achieved PASI-90 at week 16, the press release reported.

Adverse events reported in the studies showed icotrokinra had an adverse event rate within 1.1% of placebo. Studies spanning 52 weeks showed no new safety signals.

“The approval of Icotyde represents a pivotal moment for people with plaque psoriasis,” John Reed, MD, PhD, executive vice president of R&D, innovative medicine at Johnson & Johnson, said in the press release. “Icotyde is a fundamentally different treatment with the potential to redefine what physicians and patients can expect from psoriasis treatment.”