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
Amjevita, a Biosimilar to Humira, Now Available
Amjevita is supplied as a 40mg/0.8mL single-dose prefilled SureClick autoinjector, and as 20mg/0.4mL and 40mg/0.8mL single-dose prefilled syringes.
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.
Immunotherapy Combo Reduces Risk of Cancer Recurrence in Early-Stage Liver Cancer
The IMbrave050 study included 662 patients with HCC at high risk for recurrence after surgical resection or ablation with curative intent.
Controversies in the Diagnosis and Treatment of Gastroparesis
Researchers addressed common misconceptions regarding the diagnosis and treatment of gastroparesis.
December 2022 Recap: Drug Pipeline Updates
The table provided is a review of notable updates that occurred in December 2022 for investigational products in development.
Vonoprazan Looks Promising for Nonerosive Gastroesophageal Reflux Disease
The randomized, double-blind, multicenter PHALCON-NERD-301 study included 776 adults with symptomatic NERD.
FDA’s Decision on Vonoprazan Delayed Due to Nitrosamine Impurity
The FDA has established an acceptable daily intake limit for NVP of 96ng/day.
Weekly Dupilumab Beneficial in Eosinophilic Esophagitis
More patients receiving dupilumab have histologic remission, improvement in Dysphagia Symptom Questionnaire scores
FDA to Review Etrasimod NDA for Ulcerative Colitis
Etrasimod is an oral selective sphingosine 1-phosphate (S1P) receptor modulator currently being investigated to treat a range of immuno-inflammatory diseases.
