Drugs

Roche Data on Crovalimab Met Primary Endpoints

A Roche Phase 3 study called COMMODORE 2 that was evaluating the efficacy and safety of crovalimab in people with paroxysmal nocturnal hemoglobinuria (PNH) who have not been previously treated with complement inhibitors met its co-primary efficacy endpoints of transfusion avoidance and control of hemolysis. The company says that the trial data also showed that the subcutaneous drug “achieved disease control and was non-inferior to eculizumab (Alexion’s Soliris), a current standard of care, which is given intravenously every two weeks.” PNH is a rare and life-threatening blood condition in which red blood cells are destroyed by the complement system, which causes anemia, fatigue, blood clots and kidney disease.

Crovalimab is described by Roche as a “novel anti-C5 recycling monoclonal antibody designed to block the complement system – a vital part of the innate immune system that acts as the body’s first line of defense against infection.” It works by binding to C5 and blocking the last step of the complement cascade, it says, adding that it is also recycled into circulation, “enabling rapid and sustained complement inhibition. Crovalimab’s recycling action also enables low dose SC [subcutaneous] administration every four weeks.”

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