Top in GI: FDA rejects bulevirtide; risks of prophylactic endotracheal intubation
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The FDA informed Gilead that it could not approve its new drug application for bulevirtide, an investigational treatment for chronic hepatitis D virus infection and compensated liver disease.
In the complete response letter, the FDA cited issues with the manufacturing and delivery process. It was the top story in gastroenterology last week.
Another top story was about adverse events associated with prophylactic endotracheal intubation in patients with upper gastrointestinal bleeding, including an increased risk for pneumonia and extended hospital stays.
Read these and more top stories in gastroenterology below:
FDA rejects Gilead’s bulevirtide for hepatitis D, compensated liver disease
The FDA issued a complete response letter to Gilead indicating it cannot approve the company’s new drug application that seeks approval of bulevirtide for chronic hepatitis D virus infection and compensated liver disease. Read more.
Prophylactic endotracheal intubation ‘should not be performed’ for upper GI bleeding
Prophylactic endotracheal intubation prior to endoscopy was not beneficial for patients with upper gastrointestinal bleeding and was instead tied to adverse risks, researchers reported at ACG 2022 Annual Scientific Meeting. Read more.
Polyethylene glycol, ascorbic acid cleanse highly effective for colonoscopy prep
Bowel cleansing for colonoscopy with a 1 L polyethylene glycol and ascorbic acid preparation proved highly effective and tolerable, according to a real-world study. Read more.
Vonoprazan offers ‘complete, rapid, sustained’ relief in nonerosive reflux disease
Vonoprazan bested placebo for on-demand treatment of episodic heartburn in patients with nonerosive reflux disease and may offer an alternative to daily therapy, noted a presenter at the ACG Annual Scientific Meeting. Read more.
Higher-dose upadacitinib reduces disease severity, prolongs clinical remission in UC
A higher dose of upadacitinib decreased disease severity and induced clinical remission for a longer period among patients with active ulcerative colitis, according to a presenter. Read more.