Johnson & Johnson Seeks FDA Approval for Icotrokinra to Revolutionize Psoriasis Treatment

Johnson & Johnson has filed a New Drug Application with the US FDA for icotrokinra, an oral peptide to treat moderate to severe plaque psoriasis. Four Phase 3 trials showed superior efficacy over deucravacitinib and similar adverse event rates compared to placebo. Approval would expand Johnson & Johnson's immunology portfolio and offer a convenient oral option in the competitive psoriasis market.

Johnson & Johnson (NYSE: JNJ) has filed a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) for icotrokinra, an oral peptide designed to treat moderate to severe plaque psoriasis. The submission is based on robust data from four Phase 3 clinical trials, demonstrating superior efficacy over existing treatments and a favorable safety profile.

Icotrokinra is a first-in-class targeted oral peptide that selectively blocks the IL-23 receptor, a key mediator of inflammation in plaque psoriasis. The drug has shown promising results in clinical trials, meeting all primary endpoints across four Phase 3 studies, including ICONIC-LEAD, ICONIC-TOTAL, and ICONIC-ADVANCE 1 & 2 [1]. The trials demonstrated significant skin clearance rates, with efficacy comparable to injectable biologics, but with the convenience of a once-daily oral pill.

In head-to-head comparisons, icotrokinra showed superiority to deucravacitinib, an existing oral treatment, in patients with moderate-to-severe plaque psoriasis. Safety data indicated adverse event rates similar to placebo, suggesting a favorable risk-benefit profile [2]. The ongoing ICONIC-ASCEND study is further evaluating icotrokinra's efficacy and safety compared to ustekinumab, an injectable biologic.

The approval of icotrokinra would represent a significant milestone in the psoriasis treatment landscape, offering a convenient oral option in a competitive market where patient preference for oral treatments remains strong. Johnson & Johnson's submission of this NDA marks a strategic expansion of its immunology portfolio, positioning the company to capture significant market share in the psoriasis market.

References:
[1] https://www.stocktitan.net/news/JNJ/johnson-johnson-seeks-first-icotrokinra-u-s-fda-approval-aiming-to-gq17wyg4t7m4.html
[2] https://www.marketscreener.com/news/johnson-johnson-seeks-first-icotrokinra-u-s-fda-approval-aiming-to-revolutionize-treatment-paradi-ce7c5cdfd088ff25