Drugs

Medexus Pharma Refiles NDA for Treosulfan

Medexus Pharmaceuticals says its medac licensor has resubmitted its NDA for treosulfan, indicated for combination use with fludarabine as a preparative regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT). The current submission includes updates to data files and supporting information in response to an FDA information request in May when the company filed the resubmission.

The 2021 complete response letter provided recommendations specific to additional clinical/statistical data and analyses about the primary and secondary endpoints of the completed pivotal Phase 3 study, the company said at the time. Then, company officials expressed surprise at receiving the letter given treosulfan’s approval by Health Canada and the European Medicines Agency and support for it in scientific publications.

Treosulfan is part of a preparative regimen for allo-HSCT to be used in treating eligible patients with acute myeloid leukemia and myelodysplastic syndromes, according to the company. “Final study results and analysis of the pivotal Phase 3 clinical trial of treosulfan conducted by medac, which was accepted for publication with American Journal of Hematology, concluded that the study demonstrates clinically relevant superiority of treosulfan over a widely applied 'reduced-intensity conditioning' busulfan regimen with regard to its primary endpoint, event-free survival,” it says. “The publication also includes favorable conclusions on two key secondary endpoints, finding that overall survival with treosulfan was superior compared to busulfan and that non-relapse mortality for patients in the treosulfan arm was lower than for patients in the busulfan arm.”

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