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.
Diagnosis & Disease Information
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.
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.
Novel GI-Selective Therapy Gets Orphan Drug Designation for Pouchitis
The designation is supported by data from the 12-week, randomized, double-blind phase 2 FILLMORE trial.
FDA Approves Citrate-Free, High Concentration of Biosimilar Hadlima
The approval was based on data from a phase 1 study that compared the pharmacokinetics, safety, tolerability, and immunogenicity of Hadlima 100mg/mL to 50mg/mL.
FDA to Review Biosimilar Hyrimoz High Concentration Formulation
The sBLA is supported by data from a phase 1 pharmacokinetics bridging study comparing Hyrimoz 50mg/mL and citrate-free Hyrimoz HCF.
Concomitant PPI and Advanced Therapy Linked to Worse Outcomes in IBD
A team of investigators evaluated the effects of concomitant use of PPIs and advanced therapy on health care resources in patients with IBD.
Mucosa, C-Reactive Proteins Predict Ulcerative Colitis Relapse
Normalization of 2 factors can foretell the potential for recurrence in patients who were in remission, according to a report.
Antibiotic Use Increases Risk for Older-Onset Inflammatory Bowel Disease
Researchers evaluated the effects of antibiotic exposure, specifically cumulative use, timing of use, and the association with older-onset IBD.
Tofacitinib, Vedolizumab Effective for UC Post-Anti-TNF Agent Failure
Researchers compared the effectiveness of tofacitinib and vedolizumab among patients with UC who had experienced anti-TNF failure.
