Drugs

FDA Panel to Discuss CV Safety of Amgen Osteoporosis BLA

An FDA Bone, Reproductive and Urologic Drugs Advisory Committee 1/16 will discuss an Amgen BLA for romosozumab, indicated for treating osteoporosis in postmenopausal women at high risk of fracture, and a cardiovascular safety issue that arose during the submission’s earlier review that led to a complete response letter. In a briefing document about the drug’s latest review, FDA reviewers note that Amgen has proposed a Boxed Warning as well as a Warning and Precaution for cardiovascular risk.

According to FDA, two trials showed “a higher incidence of positively adjudicated cardiovascular serious adverse events during the year of romosozumab therapy.” Based on a meta-analysis of major adverse cardiovascular events (MACE) in the two studies, there were 51 (0.9%) subjects with MACE in the control group and 71 (1.3%) subjects with MACE in the romosozumab group, the agency says. One main difference between the trials is that the one with the fewer MACE events used the active control alendronate, which FDA says raises the question of “whether alendronate may confer a cardioprotective effect in the first year of therapy.”

The FDA briefing document also raises whether the cardiovascular safety outcomes seen in both trials are “generalizable to the U.S. population and U.S. medical practice given that cardiovascular risk varies among nations that enrolled subjects in these fracture trials.” Enrolled subjects from the U.S. accounted for 1.8% of subjects in one trial and 1.4% subjects in the other trial.

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