Biologics

Viela Bio BLA for Rare Autoimmune Disorder

FDA has accepted for review a Viela Bio BLA for inebilizumab, an investigational anti-CD19 monoclonal antibody for treating patients with neuromyelitis optica spectrum disorder. The rare autoimmune disease is characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis, according to the company.

The submission is based on safety and efficacy data from the pivotal N-MOmentum trial, which enrolled 231 patients with and without the AQP4-IgG antibody — a key biomarker for the disease. Viela says the trial met its primary and a majority of the secondary endpoints, with results demonstrating that inebilizumab reduced the risk of developing a disorder-related attack by 77% when compared to placebo. “In addition, inebilizumab impacted measurements of worsening disability, hospitalizations and new central nervous system MRI-detected lesions.”

The company describes inebilizumab as a humanized monoclonal antibody that binds with high affinity to CD19, a protein expressed on a broad range of B cells, including antibody-secreting plasmablasts and plasma cells. After binding to CD19, these cells are rapidly depleted from circulation, 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