Biologics

Amgen’s Uplizna OK’d for Generalized Myasthenia Gravis

FDA has approved Amgen’s Uplizna (inebilizumab-cdon) for adults with generalized myasthenia gravis (gMG) who test positive for anti-acetylcholine receptor (AChR) or anti-MuSK antibodies, giving patients a new twice-yearly biologic option aimed at sustained disease control.

Uplizna, already approved for treating neuromyelitis optica spectrum disorder (NMOSD) and IgG4-related disease, is now the first therapy targeting CD19-positive B cells approved for this segment of the gMG population. The company says by depleting a broad set of B-cell subsets, including plasmablasts and some plasma cells, the drug addresses an upstream

Approval was based on results from the Phase 3 Myasthenia Gravis Inebilizumab Trial (MINT), a 238-patient randomized, placebo-controlled study that enrolled both antibody-positive subgroups. MINT is also the first successful Phase 3 gMG trial to incorporate a structured steroid taper, according to the company.

By Week 26, 87.4% of patients receiving Uplizna and 84.6% of placebo recipients had reduced their prednisone dose to 5 mg or less per day, Amgen says. Treatment with Uplizna also led to a 1.9-point improvement over placebo in the Myasthenia Gravis Activities of Daily Living score (-4.2 vs. -2.2). In AChR+ patients, Amgen reports that improvements deepened through Week 52, with an exploratory analysis showing a 2.8-point benefit over placebo.

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