Icotrokinra seeks approval for psoriasis

[Fred]

Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionise treatment paradigm for adults and adolescents with plaque psoriasis.

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Johnson & Johnson (NYSE: JNJ) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking the first approval of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis (PsO). Icotrokinra is uniquely designed to block the IL-23 receptor, which underpins the inflammatory response in plaque PsO and offers potential in other IL-23-mediated diseases.

The application included data from four pivotal Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEAD, ICONIC-TOTAL and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2. Treatment with icotrokinra met all primary and co-primary endpoints across the development program among adults and pediatric patients 12 years of age and older with moderate-to-severe plaque PsO, demonstrating significant skin clearance and a favorable safety profile in a once-daily pill. Results from the ICONIC-ADVANCE 1 & 2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe plaque PsO. Across all studies, pooled safety data showed a similar proportion of patients experienced adverse events (AEs) between icotrokinra (49.1%) and placebo (51.9%) groups, with no new safety signals identified to date.

“The rapid patient enrollment across our ICONIC clinical program underscores the unmet need for an advanced plaque psoriasis treatment that meaningfully addresses their needs and preferences,” said Liza O’Dowd, MD, Vice President, Johnson & Johnson Innovative Medicine. “Given the breadth and depth of our studies, along with the robust clinical results reported to date, we are confident that icotrokinra has the potential to transform how physicians and patients think about plaque psoriasis care, establishing a new standard in the treatment of this immune-mediated disease.”

Johnson & Johnson has also initiated the Phase 3 ICONIC-ASCENDf study, the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab, representing an important step forward in psoriasis research.

Source: jnj.com

[mataribot]

I’d rather have a shot every 2-3 months.

[Fred]

I’d rather have a shot every 2-3 months.

Me too

[Fred]

Update:

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Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has approved Icotyde (icotrokinra), an interleukin-23 (IL-23) receptor antagonist for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 12 years of age and older who weigh at least 40 kg who are candidates for systemic therapy or phototherapy.

Source: jnj.com

[mataribot]

I’m guessing this will be over priced.

[Fred]

I’m guessing this will be over priced.

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J&J hasn’t announced how much Icotyde will cost beyond saying the company will help people pay for the medicine.

[Caroline]

Great advance !!
Certainly if it will be true if it is superior to the other biologics.

Always good to have new possibilities.

[mataribot]

Stelera blocks multiple pathways and isn’t as effective as newer biologics that block IL23A. J & J should put this up against Tremfya and more apples to apples comparisons.

[Fred]

Update: The European Medicines Agency's (EMA) recommended granting a marketing authorisation in the European Union for Icotyde (icotrokinra) for the treatment of moderate-to-severe plaque psoriasis in adults and in adolescents from 12 years of age weighing at least 40 kg.