Inflammatory bowel disease
In February 2024, the FDA put two Phase II studies of zelnecirnon under a clinical hold after a case of liver failure was deemed potentially related to the drug.
Eli Lilly and Johnson & Johnson are seeking label expansions for Omvoh and Tremfya, respectively, in Crohn’s disease following approvals for ulcerative colitis. GlobalData projects total sales for Tremfya to reach $7.8 billion globally by 2029.
At 52 weeks of follow-up, more patients on Eli Lilly’s monoclonal antibody Omvoh demonstrated histologic response, suggesting better long-term outcomes than Johnson & Johnson’s blockbuster therapy Stelara.
Tremfya’s ulcerative colitis approval on Wednesday comes as Johnson & Johnson’s blockbuster immunotherapy Stelara continues to face growing competition from biosimilars.
Back-to-back failures in psoriasis and Crohn’s disease have forced Ventyx Biosciences to abandon the development of its investigational oral TYK2 inhibitor VTX958.
Johnson & Johnson on Tuesday released Phase II/III results showing its monoclonal antibody Tremfya is better than its blockbuster Stelara in terms of endoscopic outcomes in Crohn’s disease.
Formerly known as AbGenomics Holding, AltruBio on Tuesday said it will use the funds to push its ulcerative colitis asset into a Phase IIb trial with an anticipated readout in 2026.
Data from a late-stage study showed that Bristol Myers Squibb’s Zeposia (ozanimod) was unable to significantly improve clinical remission in adult patients with moderate to severe active Crohn’s disease.
Big Pharma’s appetite for safe and effective oral IBD drugs with novel mechanisms of action continues to grow, with my former company just the latest in a string of acquisitions in the space.
Monday’s announced buyout of Virginia-based Landos Biopharma adds a mid-stage, oral NLRX1 agonist for ulcerative colitis and Crohn’s disease to AbbVie’s growing portfolio.
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