Biologics

Lilly Plans 2024 BLA for Crohn’s Drug

Eli Lilly says it will seek FDA approval in 2024 for mirikizumab after reporting the drug met the co-primary and all major secondary endpoints compared to placebo in VIVID-1, a Phase 3 study in adults with moderately to severely active Crohn’s disease. In the study, a higher proportion of patients taking mirikizumab achieved a clinical response at Week 12 and clinical remission at Week 52 compared to those on placebo (45.4% versus 19.6%), the company says.

Mirikizumab is described as an interleukin-23p19 antagonist that is currently indicated for the treatment of moderately to severely active ulcerative colitis in Japan, Germany, the United Kingdom and Canada. It works by selectively targeting the “p19 subunit of IL-23 and inhibits the IL-23 pathway,” Lilly says, adding that inflammation “due to over-activation of the IL-23 pathway plays a critical role in the pathogenesis of UC and Crohn’s disease.”

In April, FDA issued Eli Lilly a complete response letter on a BLA for mirikizumab for its use in treating ulcerative colitis (UC). In the letter, the agency cited issues related to the proposed manufacturing of mirikizumab, “with no concerns about the clinical data package, safety, or label for the medicine,” the company said at the time. Lilly recently received approval for mirikizumab as a first-in-class treatment for adults with moderately to severely active UC in Japan. Additionally, the European Medicines Agency s issued a positive opinion for mirikizumab’s use in that region.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome