Biologics

FDA Oks Sanofi’s Hemophilia A Drug

FDA has approved a Bioverativ Therapeutics (a Sanofi company) BLA for Altuviiio (efanesoctocog alfa), a recombinant DNA-derived, factor VIII concentrate indicated for use in adults and children with hemophilia A. The drug is approved for routine prophylaxis to reduce bleeding episodes, on-demand treatment and control of bleeding episodes, and perioperative management of bleeding, according to the approved label.

Sanofi recently announced positive topline results from the pivotal phase 3 XTEND-1 study in previously treated patients (N=159) at least 12 years old with hemophilia A. The study met the primary end point, showing clinically meaningful prevention of bleeding episodes in people with severe hemophilia A, who received weekly prophylaxis with efanesoctocog over 52 weeks.

The study results show the drug provides “near normal factor activity levels for an extended period of time (the majority of a week) with a single dose, which is a first for hemophilia A,” the company says. “The data show that efanesoctocog alfa can offer patients increased bleed protection, leading to improved outcomes, such as reduced pain and improved physical functioning, that may impact daily life with a reduced treatment burden.”

Additionally, Sanofi says Altuviiio is the first investigational factor VIII therapy that has been shown to “break through the von Willebrand factor ceiling, which imposes a half-life limitation on current factor VIII therapies.”

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