GLP-1 RA Use May Up Risk for Gallbladder, Biliary Diseases
GLP-1 RA treatment linked to increased risk, especially in trials for weight loss, and with higher doses and longer duration of use
Gastroenterology
Futibatinib Gets Priority Review for Locally Advanced or Metastatic Cholangiocarcinoma
The NDA submission is supported by data from the phase 2b trial evaluating futibatinib in adults with previously treated locally advanced or metastatic cholangiocarcinoma harboring FGFR2 gene rearrangements.
Management of Antithrombotics in GI Bleed, Endoscopy Addressed
Guideline addresses management of anticoagulants, antiplatelets during acute gastrointestinal bleeding and in the elective endoscopy setting
Improvements in Clinical Remission Seen With Etrasimod in UC Trial
The phase 3 ELEVATE 12 trial evaluated the efficacy and safety of etrasimod 2mg once daily vs placebo in 354 patients.
Rinvoq Approved for Moderately to Severely Active Ulcerative Colitis
The approval was based on data from two phase 3 induction studies and one phase 3 maintenance study.
USPSTF: Evidence Lacking for Screening for Eating Disorders
Evidence insufficient to support a recommendation for or against screening adults, teens for eating disorders
Vonoprazan NDA Submitted for Erosive Esophagitis
The application is supported by data from the pivotal phase 3 PHALCON-EE trial which compared the efficacy and safety of vonoprazan to lansoprazole in patients with erosive esophagitis.
February 2022 Recap: Drug Pipeline Updates
A review of regulatory and drug development status updates.
Dartisla ODT Now Available as an Adjunct to Peptic Ulcer Treatment
Dartisla ODT, an orally disintegrating tablet formulation of glycopyrrolate, to reduce symptoms of a peptic ulcer as an adjunct to treatment of peptic ulcer, is now available.
Terlipressin Decision Delayed Due to Manufacturing Facility Change
In the CRL, the FDA stated that a satisfactory inspection is required before the NDA can be approved.
