Drugs

Lilly’s Mirikizumab Hits Ulcerative Colitis Trial Endpoints

Lilly says its mirikizumab met the primary and all key secondary endpoints in the LUCENT-1 Phase 3 induction study evaluating the drug’s safety and efficacy in treating patients with moderate to severe ulcerative colitis. The company says LUCENT-2, a multicenter maintenance study in patients who completed the 12-week LUCENT-1 study is ongoing.

According to Lilly, mirikizumab met the primary endpoint of clinical remission at week 12 compared to placebo. It also met the key secondary endpoints of reduced bowel urgency, clinical response, endoscopic remission, symptomatic remission, and improvement in endoscopic histologic inflammation. It demonstrated rapid improvement in patient symptoms as early as four weeks after starting treatment, the company says.

Mirikizumab is described as a humanized igG4 monoclonal antibody that binds to the p19 subunit of interleukin 23. It is being studied for the treatment of immune diseases including psoriasis, ulcerative colitis, and Crohn’s disease.

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