Drugs

FDA Accepts for Review Hansa Biopharma Imlifidase BLA

FDA has accepted and will review the Hansa Biopharma BLA for imlifidase, which has been conditionally approved as Idefirix in several other jurisdictions for the desensitization treatment of highly sensitized adult kidney transplant patients. A company statement says imlifidase is a unique IgG-cleaving enzyme that rapidly inactivates more than 95% of donor-specific antibodies within two to six hours of administration, providing a crucial window to enable HLA (human leukocyte antigens)-incompatible kidney transplantation.

Hansa says the BLA is supported by the Phase 3 ConfideS trial in kidney transplantation that evaluated kidney function at 12 months in 64 highly sensitized transplant patients with positive crossmatch against a deceased donor. The company says the trial successfully met its primary endpoint, demonstrating significantly improved kidney function in the imlifidase arm at 12 months as measured by mean estimated glomerular filtration rate. A key secondary endpoint, dialysis independence at 12 months, was also statistically significant, Hansa says. The drug reportedly was generally well tolerated, with a safety profile consistent with previous clinical trial experience.

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