Biologics

Regeneron’s Evkeeza OK’d for Rare High Cholesterol

FDA has approved a Regeneron Pharmaceuticals BLA for Evkeeza (evinacumab-dgnb) as an adjunct to other low-density lipoprotein cholesterol (LDL-C) lowering therapies to treat adult and pediatric patients aged 12 years and older with homozygous familial hypercholesterolemia (HoFH). Evkeeza works by binding to and blocking the function of angiopoietin-like 3, a protein that plays a large role in lipid metabolism.

Approval is based on data from the Phase 3 ELIPSE HoFH trial that was published 8/2020 in the New England Journal of Medicine. The trial met its primary endpoint, with Evkeeza-treated patients reducing their LDL-C from baseline by 49% on average compared to placebo at week 24 (47% reduction Evkeeza, 2% increase placebo).

The most common adverse reactions reported from the combined safety analysis of placebo-controlled trials after 24 weeks that occurred more frequently in Evkeeza patients than placebo were nasopharyngitis (16% Evkeeza, 13% placebo), influenza-like illness (7% Evkeeza, 6% placebo), dizziness (6% Evkeeza, 0% placebo), rhinorrhea (5% Evkeeza, 0% placebo), nausea (5% Evkeeza, 2% placebo), pain in extremity (4% Evkeeza, 0% placebo) and asthenia (4% Evkeeza, 0% placebo), the company says. Adverse reactions led to treatment discontinuation in 2% of patients treated with Evkeeza, including one case of anaphylaxis that resolved with treatment, and 2% of patients who received placebo, 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