Drugs

Promising Myasthenia Gravis Trial Data: J&J

Johnson & Johnson says its Phase 3 Vivacity-MG3 study of nipocalimab in patients with generalized myasthenia gravis (gMG) demonstrated positive results. “Patients treated with nipocalimab plus standard of care (SOC) achieved superiority over placebo plus SOC as measured by the primary endpoint of improvement in the MG-ADL score from baseline over 24 weeks,” a company release says.

Patients receiving nipocalimab plus SOC improved by 4.70 points on the MG-ADL, significantly better than the 3.25 point improvement seen in patients taking the placebo plus SOC, the company says. “For someone living with gMG,” the company explains, “a 1- to 2-point change on MG-ADL may be the difference between normal eating and frequent choking on food, or shortness of breath at rest and being on a ventilator,” it says. Additionally, the study also met critical secondary endpoints.

On the safety side, J&J says the overall incidence of adverse events, serious adverse events and adverse events leading to discontinuation was similar to that in the placebo plus current SOC group.

Myasthenia gravis is an autoantibody disease in which proteins are targeted at the neuromuscular junction, disrupting neuromuscular signaling and impairing muscle contraction, according to the company. The immune system also mistakenly attacks muscle receptors by producing anti-receptor antibodies that can block or destroy the muscle receptors, preventing signals from transferring from nerves to muscles.

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