Drugs

FDA Hits Viking Therapeutics with Clinical Hold

FDA has placed a clinical hold on a Viking Therapeutics Phase 1b clinical trial of VK0214 in patients with X-linked adrenoleukodystrophy (X-ALD). The agency has requested an additional preclinical study prior to continuing the study, according to the company. “The request is not due to any findings from ongoing or previously completed studies,” it says, adding that it expects to provide the information to FDA in the second quarter.

“The company was recently informed that the FDA considers the ongoing trial to be a Phase 2 trial rather than a Phase 1b,” Viking says. “As a Phase 2 trial a rodent genotoxicity study is required prior to continuation. The company had planned to conduct this study prior to Phase 2 and will now accelerate its execution.”

VK0214 is described by Viking as a novel, orally available small molecule TRβ agonist that has been granted orphan drug designation by FDA. Results from a Phase 1 single ascending dose and multiple ascending dose study in healthy subjects showed that VK0214 demonstrated “encouraging safety and tolerability, as well as predictable pharmacokinetics.” it says. “In addition, subjects who received VK0214 experienced reductions in low-density lipoprotein cholesterol (LDL-C), triglycerides, and apolipoprotein B following 14 days of treatment.”

X-ALD is a rare and often fatal metabolic disorder characterized by a breakdown in the protective barriers surrounding brain and nerve cells (demyelination), according to the company. The disease, it says, is caused by mutations in the gene for a peroxisomal transporter of very-long chain fatty acids, which lead to dysfunction of the adrenoleukodystrophy protein, an important peroxisomal transporter, which prevents patients from efficiently metabolizing the fatty acids.

Gupta Raises Concerns About Overton’s Independence, Ideology

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Overton Confirmation Remains Uncertain After Senate Hearing

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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