October 18th, 2012
FDA Reviewers Recommend Approval of Lomitapide for Homozygous Familial Hypercholesterolemia
Larry Husten, PHD
The FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted 13-2 on Wednesday to recommend approval of Aegerion Pharmaceuticals’ cholesterol-lowering drug lomitapide for use in patients with homozygous familial hypercholesterolemia (FH). The lopsided vote does not completely reflect the views of many of the panel members, who expressed considerable concern that the drug might be used in […]
October 15th, 2012
FDA Reviewers Raise No New Red Flags Over Lomitapide
Larry Husten, PHD
FDA reviewers have raised no new concerns about lomitapide ahead of a Wednesday meeting of the Endocrinologic and Metabolic Drugs Advisory Committee. The FDA today released briefing documents that evaluate the new drug application (NDA) for lomitapide capsules, the microsomal triglyceride transfer protein (MTP) inhibitor from Aegerion Pharmaceuticals. It’s intended for use as an adjunct to a […]
June 14th, 2012
FDA Advisory Panel Recommends Expanded Indication for Sapien Transcatheter Heart Valve
Larry Husten, PHD
The FDA’s Circulatory System Devices Panel voted overwhelmingly on Wednesday to recommend an expanded indication for the Edwards Sapien Transcatheter Heart Valve in patients with symptomatic severe aortic stenosis who have high operative risk. The device is currently approved for use only in patients who are not surgical candidates. The committee voted 10-2 that the Sapien device was […]
June 11th, 2012
FDA Reviewers Raise Questions About Sapien Heart Valve System
Larry Husten, PHD
FDA reviewers have raised a number of questions about the safety and efficacy of the Sapien heart valve system. The review was published online ahead of Wednesday’s meeting of the Circulatory System Devices Panel meeting to evaluate the Sapien system for use in patients eligible but at high risk for aortic valve surgery. The Sapien system was […]
February 23rd, 2012
FDA Advisory Panel Gives Green Light to Qnexa Diet Pill
Larry Husten, PHD
Breaking a long streak of bad news for diet drugs, an FDA advisory panel on Wednesday voted 20-2 in favor of approval for Qnexa, the combination of phentermine and topiramate under development by Vivus. Panel members strongly suggested that Vivus be required to perform a cardiovascular outcomes trial, though it was not immediately clear if this […]
December 9th, 2011
FDA Advisory Panel Votes Against Implantable CardioMEMS HF Pressure Measurement System
Larry Husten, PHD
Members of the FDA Circulatory System Devices Panel on Thursday recommended against approval of the implantable CardioMEMS HF Pressure Measurement System. Although panel members agreed that the device was safe by a 9-1 vote, they voted 7-3 that the device had not been shown to be effective and 6-4 that the benefits did not outweigh the risks. […]
December 6th, 2011
FDA Reviewers Raise Questions About CardioMEMS CHAMPION Trial Ahead of Advisory Panel
Larry Husten, PHD
FDA reviewers have raised serious questions about the results of the CHAMPION trial of the implantable CardioMEMS HF Pressure Measurement System (HF System), which provides daily pulmonary artery pressure measurements for the purpose of guiding heart failure treatment. On December 8, the FDA’s Circulatory System Devices Panel is scheduled to review the PMA for the device. (Click here […]
October 28th, 2011
FDA Advisory Panel Votes 8-2 Against Approval of Medtronic AF Ablation System
Larry Husten, PHD
An FDA advisory panel has recommended against approval of Medtronic’s Ablation Frontiers Cardiac Ablation System for the treatment of symptomatic, drug refractory, persistent atrial fibrillation (AF) or longstanding persistent AF of up to four years in duration. In an 8-2 vote, members of the Circulatory System Devices Panel said that the risks of the device outweighed its […]
September 6th, 2011
FDA Reviewers Recommend Complete Response Letter for Rivaroxaban (Xarelto)
Larry Husten, PHD
FDA reviewers have recommended against the approval of rivaroxaban (Xarelto, Johnson & Johnson), which will be the subject of a Cardiovascular and Renal Drugs Advisory Committee meeting on Thursday. The recommendation comes as a surprise, as many physicians and analysts had expected an easy approval for the drug. The bottom line from the FDA reviewers is […]
August 10th, 2011
Rethinking Trilipix — And the Process for Approving Lipid-Modifying Drugs
Sanjay Kaul, MD
Editor’s Note: In an article published in the New England Journal of Medicine, three members of the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (Allison Goldfine, Sanjay Kaul, and William Hiatt) offer their perspective on the May 19 committee meeting to review the controversial ACCORD-Lipid Study. Here, one of those authors, Sanjay Kaul, provides his […]
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