Drugs

Lilly’s Ulcerative Colitis Therapy Approved

FDA has approved an Eli Lilly BLA for Omvoh (mirikizumab-mrkz) infusion (300 mg/15 mL)/injection (100 mg/mL), described as the first interleukin-23p19 (IL-23p19) antagonist for treating moderately to severely active ulcerative colitis in adults.

Approval was based on data from two Phase 3 trials (LUCENT) showing that after 12 weeks of Omvoh treatment, “nearly two-thirds (65%) of patients achieved clinical response and nearly one-fourth (24%) achieved clinical remission compared to placebo (43% and 15%, for clinical response and clinical remission, respectively),” Lilly says. “Among those who achieved clinical response at 12 weeks, Omvoh demonstrated consistent efficacy across subgroups, with 51% of all patients and 45% of patients who failed prior treatment with a biologic or Janus kinase inhibitor (JAKi) achieving clinical remission at one year compared to placebo (27% and 15%, respectively). Among those who achieved clinical response at 12 weeks, one-half (50%) achieved steroid-free clinical remission at one year, compared to placebo (27%).”

On the safety side, Lilly says that patients taking Omvoh were less likely to discontinue treatment due to adverse events compared to placebo. The most common adverse reactions associated with Omvoh were upper respiratory infections, injection site reactions, arthralgia, rash, headache and herpes viral infection, it says.

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