Drugs

Orphan Status for Green Tea Extract in Pouchitis

FDA has granted PharmassêtX an orphan drug designation for epigallocatechin gallate (EGCG), described by the company as a well-characterized component of green tea for treating inflammatory bowel disease (IBD) pouchitis, which is experienced by a number of patients who have undergone surgery to remove their large intestine. There is currently no FDA-approved drug for the treating the condition.

The designation is based on data from a clinical study of an EGCG-enriched green tea extract that showed patients suffering from mild to moderate ulcerative colitis, a common form of IBD, experienced clinical improvement, including endoscopic improvement, after treatment. Additionally, the company cites peer-reviewed evidence of EGCG’s safety and effectiveness from a retrospective study of pouchitis patients published in the International Journal of Colorectal Diseases. “The majority of refractory pouchitis patients experienced complete relief from their symptoms, with no serious adverse events reported,” it says.

PharmassêtX says EGCG has been “shown to target NF-κB, a key regulator of mucosal immunity, which promotes the expression of multiple pro-inflammatory genes dysregulated in IBD. Additional effects may include decreased activation of the NLRP3 inflammasome, decreased secretion of pro-inflammatory interleukins, and promotion of intestinal barrier integrity. Studies in relevant IBD models suggest that targeting NF-κB can be an effective strategy in disease management, whether alone or as an adjunct in combination with other therapeutics.”

The company says it has recently partnered with contract research organization Alimentiv to advance its EGCG drug (PSX-514) into clinical trials in 2025.

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