Drugs

FDA OKs Ionis’ Hereditary Angioedema Drug

FDA has approved an Ionis Pharmaceuticals NDA for Dawnzera (donidalorsen) as the first RNA-targeted prophylactic treatment for hereditary angioedema (HAE) in patients 12 years and older. The drug is designed to block plasma prekallikrein, a protein that drives the inflammatory force behind HAE attacks, according to the company. The self-administered subcutaneous injection is intended for use once every four or eight weeks, the longest dosing interval currently available for HAE prophylaxis, Ionis says.

Approval was based on data from the pivotal Phase 3 OASIS-HAE trial, which saw Dawnzera cut monthly attack rates by 81% compared with placebo over 24 weeks, meeting its primary endpoint, according to the company. Attack reductions rose to 87% when measured from the second dose, while moderate-to-severe episodes fell by about 90%, it says.

Ionis says that a separate switch study found that patients moving from existing prophylactic therapies, including lanadelumab and C1-esterase inhibitors, experienced a further 62% reduction in attack rates.

Across clinical studies, Dawnzera showed a favorable safety profile, according to the company. The most common side effects included injection site reactions, upper respiratory tract infections, urinary tract infections and abdominal discomfort.

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