Johnson & Johnson seeks FDA approval for new psoriasis drug

Published 21/07/2025, 13:24
Johnson & Johnson seeks FDA approval for new psoriasis drug

SPRING HOUSE, Pa. - Johnson & Johnson (NYSE:JNJ) submitted a New Drug Application to the U.S. Food and Drug Administration for icotrokinra, a first-in-class oral peptide designed to treat moderate to severe plaque psoriasis in patients 12 years and older.

The application is based on data from four Phase 3 clinical trials in the ICONIC program, which showed the once-daily pill met all primary endpoints for skin clearance. The studies included head-to-head comparisons with deucravacitinib and evaluations of difficult-to-treat skin areas such as the scalp and genitals. As a prominent player in the pharmaceuticals industry, Johnson & Johnson’s strong research and development capabilities are backed by robust cash flows and moderate debt levels, as revealed in InvestingPro’s comprehensive analysis.

According to the company, pooled safety data showed adverse events occurred at similar rates between icotrokinra (49.1%) and placebo (51.9%) groups, with no new safety signals identified.

"The rapid patient enrollment across our ICONIC clinical program underscores the unmet need for an advanced plaque psoriasis treatment," said Liza O’Dowd, Vice President at Johnson & Johnson Innovative Medicine.

The company has also initiated ICONIC-ASCEND, described as the first study comparing an oral pill to an injectable biologic (ustekinumab) for psoriasis treatment.

Plaque psoriasis affects approximately 8 million Americans and 125 million people worldwide, with nearly one-quarter of cases considered moderate-to-severe. The condition causes inflamed, scaly patches that may appear anywhere on the body, particularly on the scalp, knees, elbows, and torso. With 14 analysts recently revising their earnings estimates upward, InvestingPro analysis suggests Johnson & Johnson is well-positioned to capitalize on this significant market opportunity. Subscribers can access detailed financial metrics and 8 additional ProTips about JNJ’s market position and growth potential.

Icotrokinra works by selectively blocking the IL-23 receptor, which plays a key role in the inflammatory response in psoriasis. The drug was jointly discovered by Protagonist Therapeutics and Johnson & Johnson under a license and collaboration agreement established in 2017.

This article is based on a press release statement from Johnson & Johnson.

In other recent news, Johnson & Johnson’s second-quarter performance exceeded expectations, with the company reporting adjusted operational sales growth of 3.0% year-over-year. This strong performance led RBC Capital to raise its price target for the company to $185, while UBS increased its target to $190, citing robust sales growth in the innovative medicines portfolio. Guggenheim also adjusted its price target to $167, maintaining a Neutral rating despite acknowledging better-than-expected results from both the Innovative Medicine and MedTech segments. Additionally, the U.S. Food and Drug Administration granted Priority Review to Johnson & Johnson’s bladder cancer drug, TAR-200, which showed promising results in clinical trials. Goldman Sachs raised its price target to $185, highlighting strong momentum in key products and resilience against Stelara biosimilar competition. The investment bank also noted potential for continued upward revisions to earnings and sales estimates. These developments reflect a period of strategic growth and innovation for Johnson & Johnson, as the company navigates challenges such as Stelara’s loss of exclusivity and ongoing litigation issues.

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