FDA experts shrug off retinopathy concerns, offer (near) unanimous thumbs up for Novo Nordisk's semaglutide
An FDA panel of outside experts today voted almost unanimously to endorse Novo Nordisk’s next big diabetes/obesity drug semaglutide, likely setting up a near-term approval for one of this year’s top blockbusters in the pipeline. There was one abstention and zero opposition to the key question.
Novo Nordisk is a major player in diabetes and predictably ran a thorough late-stage effort to nail down their drug’s ability to lower HbA1c — a critical measure for the control of the disease. In the process, though, they also carefully tracked incidents of diabetic retinopathy — damage to the blood vessels in the eye, which can lead to blindness — spotlighting what would become a big issue for its scientists on Wednesday.
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