Drugs

Astellas Wins Revised Label for Izervay

FDA has approved an Astellas Pharma supplemental NDA for Izervay (avacincaptad pegol intravitreal solution) that revises the labeling for the drug’s use in treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The approval cover’s Izervay’s use without a limitation on duration of dosing, according to the company. It was based on positive two-year data from the GATHER2 Phase 3 clinical trial, which evaluated the efficacy and safety of monthly and every other month dosing through two years, it says.

In 11/2024, FDA issued Astellas a complete response letter on the supplemental NDA, which at the time the company said the concerns were “unrelated to the safety and benefit/risk of the use of Izervay; rather, the comments [in the CRL] focused on a statistical matter related to labeling language proposed by Astellas.”

Izervay was originally approved 8/2023 for treating GA secondary to AMD. As AMD progresses, retinal cell loss and the underlying blood vessels in the macula results in “marked thinning and atrophy of retinal tissue,” the company says. “Geographic atrophy, associated with AMD, leads to further irreversible loss of vision in these patients.”

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