Johnson & Johnson Submits Application to EMA for Plaque Psoriasis Treatment

Johnson & Johnson has submitted an application to the European Medicines Agency (EMA) for its plaque psoriasis treatment. The company is a leading producer of healthcare products, with a portfolio that includes pharmaceutical products and medical equipment. Net sales break down into pharmaceutical products (64.1%) and medical products and equipment (35.9%).

Johnson & Johnson has submitted an application to the European Medicines Agency (EMA) for its plaque psoriasis treatment, icotrokinra. This submission follows a U.S. FDA NDA filing in late July and is supported by comprehensive clinical data demonstrating the potential of icotrokinra to disrupt the current treatment paradigm for plaque psoriasis.

Icotrokinra, a first-in-class investigational targeted oral peptide, selectively blocks the IL-23 receptor, which underpins the inflammatory response in plaque psoriasis. The application includes data from four Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 & 2. These studies demonstrated significant skin clearance and a favorable safety profile with the simplicity of a once-daily tablet.

The submission underscores icotrokinra's potential to offer moderate-to-severe plaque psoriasis patients the combination of complete skin clearance and a favorable safety profile, relative to comparators, with the simplicity of a once-daily tablet Protagonist Announces Icotrokinra Application for Approval in Plaque Psoriasis Submitted to the European Medicines Agency^[1].

Johnson & Johnson's submission comes on the heels of a U.S. FDA NDA filing in late July, both of which are supported by a very comprehensive clinical data package demonstrating the significant impact icotrokinra has in the clinical setting . The company is looking forward to sharing additional data in ongoing studies, including the ANTHEM ulcerative colitis 12-week data at the upcoming United European Gastroenterology meeting and data from the ICONIC-LEAD and ICONIC-ADVANCE trials being presented at the European Academy of Dermatology and Venereology Congress in Paris next week .

Johnson & Johnson's submission to the EMA is a significant milestone in the development of icotrokinra, which has shown promising results in clinical trials. This submission highlights the company's commitment to developing innovative treatments for chronic immune-mediated diseases.

About Johnson & Johnson
Johnson & Johnson is a leading producer of healthcare products, with a portfolio that includes pharmaceutical products and medical equipment. Net sales break down into pharmaceutical products (64.1%) and medical products and equipment (35.9%) . The company's diverse portfolio and extensive research and development capabilities position it well to continue driving innovation in healthcare.

References:
Protagonist Announces Icotrokinra Application for Approval in Plaque Psoriasis Submitted to the European Medicines Agency^[1] Protagonist Therapeutics, Inc. (2025). Protagonist Announces Icotrokinra Application for Approval in Plaque Psoriasis. Accessed September 10, 2025.
Protagonist Therapeutics, Inc. (2025). Protagonist Announces Icotrokinra Application for Approval in Plaque Psoriasis. Accessed September 10, 2025.
Protagonist Therapeutics, Inc. (2025). Protagonist Announces Icotrokinra Application for Approval in Plaque Psoriasis. Accessed September 10, 2025.
Johnson & Johnson Annual Report (2024).