Drugs

Astellas Gets ‘Complete Response’ on Izervay sNDA

FDA has issued Astellas Pharma a complete response letter (CRL) on a supplemental NDA for Izervay (avacincaptad pegol intravitreal solution) seeking revised drug labeling for its use in treating geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The company says the agency’s comments in the CRL are “unrelated to the safety and benefit/risk of the use of Izervay; rather, the comments focus on a statistical matter related to labeling language proposed by Astellas.”

FDA 8/2023 approved Izervay 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 said at the time. “Geographic atrophy, associated with AMD, leads to further irreversible loss of vision in these patients.”

The company says the supplemental NDA was seeking approval to include positive two-year data in the drug’s U.S. prescribing information based on results from the GATHER2 Phase 3 clinical trial, which evaluated the efficacy and safety of monthly and every other month dosing through two years.

Astellas says it is seeking further clarification from FDA so it can address the agency’s feedback.

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