Drugs

Biogen, AbbVie Pulling Zinbryta Globally

FDA says Biogen and AbbVie are withdrawing their multiple sclerosis drug Zinbryta (daclizumab) from the global market due to concerns about the drug’s benefit/risk profile. In an online information sheet, the agency says it is working with the companies to help ensure a well-organized withdrawal from the market in the U.S. and to ensure that healthcare professionals have information they need to transition their Zinbryta patients to another treatment.

Zinbryta’s complex safety profile has been recognized since the time of FDA approval, the notice says. The safety profile led to an indication of use generally limited to patients who have had an inadequate response to two or more multiple sclerosis drugs, to a Boxed Warning about the risk of liver injury and other immune-mediated disorders, and to a Risk Evaluation and Management Strategy making the drug available only through a restricted distribution program. FDA says it has continuously monitored adverse events associated with the drug’s use and has updated product labeling as new information became available.

The European Medicines Agency recently announced a Zinbryta recall following 12 reports of serious inflammatory brain disorders worldwide. FDA says it is conducting its own review of similar events.

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