Drugs

FDA Puts Clinical Hold on Genentech MS Studies

FDA has placed a clinical hold on a Genentech multiple sclerosis clinical development program for fenebrutinib. The agency action was based on two recent cases of hepatic transaminase (liver enzyme) elevations along with elevated bilirubin that suggests a drug-induced liver injury that was observed in the blinded Phase 3 FENhance relapsing multiple sclerosis studies. “Both patients were asymptomatic and elevations returned to normal levels following drug discontinuation,” the company says.

New enrollment for the Phase 3 FENhance I trial in the U.S. is paused, while enrollment continues in other countries. “Participants in the U.S. who have received the study drug for more than 70 days will continue treatment in all studies,” the company says. “A small number of participants in the U.S. who have received the study drug for 70 days or less will discontinue treatment.”

Fenebrutinib is an investigational oral, reversible and non-covalent Bruton’s tyrosine kinase (BTK) inhibitor that blocks the function of BTK, an enzyme that regulates B-cell development and activation and is also involved in the activation of innate immune system myeloid lineage cells, such as macrophages and microglia, Genentech says. “Preclinical data have shown fenebrutinib to be potent, highly selective, and it is the only reversible inhibitor currently in Phase III trials for MS,” it adds.

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