Drugs

Arrowhead Acquires Priority Voucher to Speed Plozasiran Expanded Indication

Arrowhead Pharmaceuticals has agreed to acquire an FDA Rare Pediatric Disease Priority Review Voucher for $215 million from an undisclosed third party. The Pasadena, CA--based company says it intends to use the voucher for a supplemental NDA it plans to file before the end of the year to add “severe hypertriglyceridemia (sHTG)” to Redemplo’s (plozasiran) approved indications. If accepted for review, the voucher would provide a six-month review timeline.

"The recent topline results for the global Phase 3 SHASTA-3 and SHASTA-4 clinical studies have strengthened our confidence in the potential for plozasiran to transform the treatment of patients with sHTG," Arrowhead president and chief executive officer Christopher Anzalone said in a statement.

Severe hypertriglyceridemia is characterized by triglyceride levels above 500 mg/dL and is associated with a substantially increased risk of acute pancreatitis, a potentially life-threatening condition that often results in repeated hospitalizations. Current treatment options capable of producing sustained reductions in triglyceride levels remain limited, the company says.

Redemplo is already approved as an adjunct to diet to reduce triglyceride levels in adults with familial chylomicronemia syndrome, a rare genetic disorder that represents the most severe form of hypertriglyceridemia.

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