Drugs

Panel Backs Expanded Onpattro Use

FDA’s Cardiovascular and Renal Drugs Advisory Committee 9/13 voted 9 to 3 that the benefits of Alnylam Pharmaceuticals’ patisiran (Onpattro) outweigh its risks for treating cardiomyopathy induced by transthyretin amyloidosis (ATTR). Panel members who voted favorably for the drug agreed that while the benefit was small, any safety risks were equally as small. Onpattro was approved by FDA in 2018 to treat hereditary ATTR amyloidosis polyneuropathy.

During the advisory committee meeting, the majority of the panel members dismissed agency medical reviewers who questioned patisiran’s efficacy in treating a larger pool of patients as sought in the company’s sNDA. In a briefing document released in advance of the committee meeting, FDA said that while the APOLLO-B study submitted with the sNDA was well designed and executed and met a key primary endpoint and a key secondary endpoint, with the results being statistically significant, the agency found that “the effects of patisiran compared to placebo on both endpoints were small, of questionable clinical meaningfulness, and may not be detectable by patients.”

An FDA review action on the drug is expected on or before 10/8.

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