The Healio article reports on a series of significant FDA approvals in the field of gastroenterology and hepatology towards the end of 2023, particularly focusing on treatments for ulcerative colitis (UC). The FDA approved four new therapies for UC, which are expected to compete in an already crowded market. These include Eli Lilly’s IL-23p19 inhibitor Omvoh (mirikizumab), Pfizer’s Velsipity (etrasimod), Takeda Pharmaceuticals’ Entyvio (vedolizumab), and Celltrion USA’s Zymfentra (infliximab-dyyb).
The article highlights the potential market impact of these new treatments, which will be competing with established drugs like Stelara, Humira, and Xeljanz. Additionally, the FDA approved treatments for erosive esophagitis or erosive gastroesophageal reflux disease, and Helicobacter pylori infection. The article also mentions other significant FDA actions, including the approval of a subcutaneous formulation of Entyvio for UC, fast track designation for a monoclonal antibody for primary sclerosing cholangitis, and the expansion of Veklury’s approval as a COVID-19 treatment for patients with liver disease. This flurry of approvals indicates a dynamic period in the treatment of gastrointestinal diseases, particularly UC.