FDA Policy/General

Amgen’s Uplizna OK’d for Immunoglobulin G4 Disease

FDA has approved an Amgen supplemental BLA for Uplizna (inebilizumab-cdon) for treating adults living with immunoglobulin G4-related disease (IgG4-RD), which is described as a chronic and debilitating immune-mediated inflammatory condition that can affect and damage multiple organs. The approval is based on data from the MITIGATE trial that showed Uplizna’s potential to decrease disease activity by reducing flares in patients, according to the company. Uplizna was originally approved in 2020 for treating adult patients with AQP4-IgG+ neuromyelitis optica spectrum disorder.

Amgen says data from MITIGATE trial showed an 87% reduction in the risk of IgG4-RD flares in Uplina-treated patients compared to placebo. It also showed a reduction in the annualized flare rate for patients treated with the therapy. Additionally, 57.4% of Uplizna patients achieved flare-free, treatment-free, and complete remission at Week 52 compared to 22.4% of those taking a placebo, according to the company.

Amgen says the most common adverse reactions in patients with IgG4-RD were urinary tract infections (12% of patients treated) and lymphopenia (19%).

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

Read more

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