Drugs

BMS, Janssen Moving Stroke Drug to Phase 3

Bristol Myers Squibb and Janssen Pharmaceuticals announced 8/28 that they are planning to begin a Phase 3 trial of their investigational oral factor XIa (FXIa) inhibitor, milvexian, after reporting results from the Phase 2 AXIOMATIC-SSP dose-ranging study that showed a 30% relative risk reduction in recurrent symptomatic ischemic strokes and “favorable” safety profile in three arms compared to placebo when used in combination with background antiplatelet therapy in patients with an acute non-cardioembolic ischemic stroke or transient ischemic attack. The data were presented at the European Society of Cardiology (ESC) Congress 2022 in Barcelona, Spain.

In the Phase 2 study, the companies said the primary objective was to “detect a dose response for the composite endpoint of symptomatic ischemic stroke + MRI-detected covert brain infarction across a 16-fold dose range…,” but a dose response was not observed. “A relative risk reduction of approximately 30% in symptomatic ischemic stroke with milvexian was observed in patients receiving either 25, 50 or 100 mg twice daily compared to placebo,” they explained.

“There was no increase in severe bleeding (e.g., symptomatic intracranial hemorrhage) versus placebo, and there was no fatal bleeding in any arm of the study, even with all patients on background dual antiplatelet therapy for 21 days followed by single antiplatelet therapy for the duration of the trial,” the companies said. “The rate of major bleeding for milvexian 25 mg once daily and twice daily doses was similar to placebo, while a numerical increase was observed in milvexian dose arms of 50 mg twice daily and above, with no dose-response.

“Early stroke recurrence after ischemic stroke or transient ischemic attack (TIA) remains a significant risk despite advances in secondary prevention,” they continued. “Due to bleeding concerns, there are currently no anticoagulants used when a patient suffers an acute non-cardioembolic ischemic stroke; however, these data suggest that milvexian has potential to improve outcomes for stroke patients in clinical practice.”

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