January 2023 Recap: Drug Pipeline Updates
The table provided is a review of notable updates that occurred in January 2023 for investigational products in development.
Diagnosis & Disease Information
Tukysa Combo Approved for RAS Wild-Type, HER2-Positive Metastatic Colorectal Cancer
The approval was based on data from the phase 2 MOUNTAINEER trial, which included patients with HER2-positive unresectable or metastatic colorectal cancer.
Obeticholic Acid Under Review for Pre-Cirrhotic Liver Fibrosis Due to NASH
The NDA is supported by two 2 positive interim analyses from the phase 3 REGENERATE trial that included patients with biopsy-proven stage 2 or 3 liver fibrosis due to NASH.
Antibiotic Exposure Positively Linked to IBD Development
Positive dose-response seen for all aged 10 years and older, with greatest risks for those aged 40 to 60 years and 60 years and older
Weekly Dupilumab Beneficial in Eosinophilic Esophagitis
More patients receiving dupilumab have histologic remission, improvement in Dysphagia Symptom Questionnaire scores
Idacio, a Citrate-Free Biosimilar to Humira, Gets FDA Approval
The approval for Idacio was based on a review of data that showed similar pharmacokinetics, efficacy, safety, and immunogenicity to the reference adalimumab product.
Xeloda Labeling Updated Under FDA’s New Program for Older Oncology Drugs
Project Renewal is an Oncology Center of Excellence initiative that aims to update the labeling information for certain older oncology drugs.
Lonafarnib-Based Regimens Look Promising for Patients With Chronic HDV Infection
The all-oral and combination treatment arms demonstrated statistically significant composite responses of 10.1% and 19.2%, respectively.
November 2022 Recap: Drug Pipeline Updates
The table provided is a review of notable updates that occurred in November 2022 for investigational products in development.
Eradicating H. pylori Cuts Aspirin-Related Peptic Ulcer Bleeding in the Short Term
Protection against aspirin-associated peptic ulcer bleeding in older adults lost after the first 2.5 years
