Johnson & Johnson Submits NDA for Protagonist-Partnered Icotrokinra to FDA for Plaque Psoriasis

Protagonist Therapeutics Inc. (NASDAQ:PTGX) is one of the best mid cap pharma stocks to buy. On July 21, Protagonist Therapeutics announced that Johnson & Johnson (NYSE:JNJ) submitted a New Drug Application/NDA to the US FDA for icotrokinra. This submission seeks the first approval for icotrokinra, which is a first-in-class investigational targeted oral peptide, for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis.

Icotrokinra is designed to selectively block the IL-23 receptor, which drives inflammation in plaque psoriasis and potentially other IL-23-mediated diseases. Icotrokinra was jointly discovered and is being developed under a license and collaboration agreement between Protagonist and Johnson & Johnson. The NDA filing is supported by an extensive data package from 4 pivotal Phase 3 studies within the ICONIC clinical development program: ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2.

Johnson & Johnson Submits NDA for Protagonist-Partnered Icotrokinra to FDA for Plaque Psoriasis

A closeup of a laboratory assistant, holding up a vial of a newly developed pharmaceutical product.

Icotrokinra met all primary and co-primary endpoints across these studies and showed significant skin clearance and a favorable safety profile as a once-daily pill for adults and pediatric patients aged 12 and older with moderate-to-severe plaque psoriasis. Notably, ICONIC-ADVANCE 1 and 2 showed icotrokinra’s superiority to deucravacitinib.

Protagonist Therapeutics Inc. (NASDAQ:PTGX) is a biopharmaceutical company that develops peptide therapeutics for hematology and blood disorders, and inflammatory and immunomodulatory diseases.

Johnson & Johnson (NYSE:JNJ) researches, develops, manufactures, and sells various products in the healthcare field worldwide.

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Disclosure: None. This article is originally published at Insider Monkey.