Drugs

J&J Seeks Approval for Oral Peptide for Psoriasis

Johnson & Johnson has submitted an NDA for icotrokinra, which it describes as a first-in-class oral therapy for moderate to severe plaque psoriasis. If approved, icotrokinra would be the first targeted oral peptide to block the interleukin-23 (IL-23) receptor for both adults and adolescents aged 12 and older.

The submission is based on data from four Phase 3 clinical trials in the ICONIC program, showing that the therapy met all primary and co-primary endpoints and demonstrated superiority to deucravacitinib, a current oral psoriasis treatment, according to the company. The data also highlighted the drug’s effectiveness in treating difficult-to-treat scalp and genital psoriasis, with a safety profile comparable to placebo, it says.

J&J says it has also launched ICONIC-ASCEND, a Phase 3 head-to-head trial comparing icotrokinra with the company’s injectable biologic Stelar (Ustekinumab). If successful, the study could position icotrokinra as the first oral psoriasis therapy to outperform an established injectable treatment, it adds.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome