Drugs

Ionis' Olezarsen Priority Review for Severe Hypertriglyceridemia

FDA has accepted for priority review an Ionis Pharmaceuticals supplemental NDA for olezarsen for treating severe hypertriglyceridemia (sHTG). It's currently approved as Tryngolza for familial chylomicronemia syndrome in the U.S. The agency set a user fee review action target date of 6/30.

Ionis said the submission’s acceptance was seen as recognition of an "urgent need" for better options. Current therapies offer limited benefits against recurrent acute pancreatitis attacks, which carry serious long-term risks, it says. Olezarsen could become the first treatment proven to reduce these potentially life-threatening events.

The submission is based on data from the Phase 3 CORE (NCT05079919; n=617) and CORE2 (NCT05552326; n=446) trials, according to the company. Olezarsen, given as 50 mg or 80 mg subcutaneous injections every four weeks, cut triglyceride levels by up to 72% versus placebo at six months, the data show. It also reduced pancreatitis events by 85%, with nearly 90% of patients reaching levels under 500 mg/dL — below the pancreatitis risk threshold. Safety and tolerability were favorable, it says.

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