Drugs

FDA Approves Alexion’s Ultomiris

FDA has approved Alexion Pharmaceuticals’ Ultomiris (ravulizumab) to treat adult patients with paroxysmal hemoglobinuria (PNH). An agency announcement says PNH is a rare acquired disorder that leads to the rupture or destruction of red blood cells (hemolysis).

Ultomiris is described as a long-acting complement inhibitor that prevents hemolysis. Its efficacy was studied in a clinical trial of 246 patients who previously had not been treated for PNH and were randomized to be treated with Ultomiris or eculizumab (Alexion’s Soliris), the current standard of care for PNH. FDA says the trial results demonstrated that Ultomiris had similar results to Soliris in that patients did not receive a transfusion and had similar incidence of hemolysis.

Common side effects reported by patients in clinical trials were headache and upper respiratory infection. The drug’s labeling includes a Boxed Warning about the risk of life-threatening meningococcal infections and sepsis.

The application had been granted priority review and orphan drug designation.

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