Drugs

FDA Orphan Drug Status for Felzartamab

FDA has granted Human Immunology Biosciences an orphan drug designation for felzartamab, an investigational agent for treating primary membranous nephropathy (PMN). The monoclonal antibody is designed to deplete CD38+ plasma cells, which are believed to drive PMN through the production of pathogenic autoantibodies, the company says.

PMN is a rare immune-mediated disease affecting the kidneys of more than 36,000 people in the United States. The company says there are currently no approved therapies for PMN, and standard of care comprises immunosuppressive therapies like cyclophosphamide and CD20-targeted B-cell depleting agents. “Even with these strategies, half of patients with PMN continue to have nephrotic syndrome and nearly one third progress to kidney failure,” Human Immunology Biosciences says.

Two recently announced studies showed that elzartamab produced a dose-dependent reduction in pathogenic antibody levels, according to the company. Felzartamab is also being evaluated in investigator-initiated studies for PMN in patients who have had inadequate response to anti-CD20 and for antibody mediated rejection of renal allograft transplants.

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