Biologics

FDA Approves First Drug for Warm Autoimmune Hemolytic Anemia

FDA has approved a Janssen Biotech BLA for Imaavy (nipocalimab-aahu) injection for warm autoimmune hemolytic anemia (wAIHA) in adult and pediatric patients 12 years of age and older currently or previously treated with corticosteroids. The rare blood disorder causes a patient’s immune system to mistakenly attack and destroy the body’s own red blood cells (hemolysis). Because the destruction occurs fast, the body is slow to replace red blood cells, leading to anemia.

“Normally, red blood cells live about 120 days and deliver oxygen throughout the body. In wAIHA, a type of antibody called immunoglobulin G (IgG) mistakenly tags red blood cells for destruction by immune cells,” an FDA release explains. “The disease is called 'warm' because this process occurs at normal body temperature.”

Approval is based on data from the wAIHA Study (NCT04119050), a 24-week, randomized, double-blind, placebo-controlled clinical trial. In the study, 118 patients were randomly assigned to one of three treatment groups: Imaavy 30 mg/kg given by IV infusion once every four weeks; Imaavy 15 mg/kg given by IV infusion once every two weeks; or placebo.

FDA says that the proportion of patients with a durable hemoglobin response was 24% in the Imaavy 30 mg/kg arm compared to 8% in the placebo arm, adding that the 15 mg/kg arm did not lead to a higher proportion of patients with a durable hemoglobin response.

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