Drugs

Momenta Begins Phase 2/3 Nipocalimab Study

FDA has allowed Momenta Pharmaceuticals to proceed under its IND to begin an adaptive Phase 2/3 clinical study for its FcRn inhibitor nipocalimab (M281) in warm autoimmune hemolytic anemia (wAIHA). If successful, the adaptive Phase 2/3 study could serve as a pivotal study which could enable nipocalimab to be the first treatment option for wAIHA patients, the company says.

The randomized, double blind, placebo-controlled, multi-center clinical trial will investigate the efficacy, safety and tolerability of nipocalimab in patients with wAIHA. The rare autoimmune hemolytic anemia is characterized by the destruction of red blood cells due to the presence of pathogenic IgG autoantibodies. “Destruction of red blood cells results in severe anemia, leading to weakness and fatigue,” the company says. “Up to 8% of wAIHA patients may die prematurely, with those experiencing active and uncontrolled hemolysis most at risk. Rates as high as 30% have been observed for wAIHA patients with severe disease admitted to an ICU.”

Momenta says it developed the human, anti-FcRn, aglycosylated IgG1 monoclonal antibod using its proprietary antibody engineering technology. In patients with wAIHA, nipocalimab is expected to reduce the physical and laboratory manifestations of the disease by blocking FcRn-mediated recycling of IgG and reducing circulating levels of antibodies, including the pathogenic autoantibodies that cause wAIHA, it says.

Nipocalimab is also being evaluated in two ongoing Phase 2 trials. One is the Vivacity-MG clinical trial, a randomized, double-blinded, placebo-controlled multi-dose trial in 60 generalized myasthenia gravis patients. The other is the Unity trial, an open label Phase 2 clinical trial of nipocalimab in 15 pregnant women at high risk for early onset severe hemolytic disease of the fetus and newborn.

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

Read more

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