Drugs

FDA Broadens Use of Amgen’s Repatha

FDA has expanded the approved use of Amgen’s cholesterol-lowering drug Repatha (evolocumab) to include adults at increased risk of major adverse cardiovascular events due to uncontrolled low-density lipoprotein cholesterol (LDL-C), even if they have not been diagnosed with cardiovascular disease. The change removes a key limitation on the drug’s use, potentially opening treatment to millions of patients struggling to manage “bad cholesterol” with statins or unable to tolerate them, the company says.

“Far too many adults at risk of cardiovascular disease are not achieving their LDL-C goals, despite it being one of the most modifiable risk factors for a heart attack or stroke,” Amgen says. said “This label update highlights the real-world need for additional treatment options for at-risk patients.”

Alongside the broader cardiovascular risk indication, FDA’s action also expanded Repatha’s use as monotherapy for patients with homozygous familial hypercholesterolemia, a rare genetic disorder that causes extremely high cholesterol levels. The company reiterates that Repatha should be used in combination with diet and exercise.

Repatha is described by the company as a PCSK9 inhibitor designed to reduce LDL-C by preventing degradation of LDL receptors in the liver.

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