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Latest From Sue Sutter
Novo Nordisk's once-weekly GLP-1 agonist can address diabetic retinopathy complications through labeling, US FDA advisory committee says in endorsing approval; panelists say a postmarketing study on retinopathy would be desirable and could be folded into a larger cardiovascular outcomes trial.
Once-weekly GLP-1 agonist was associated with higher risk of diabetic retinopathy complications in the SUSTAIN-6 trial, but Novo says this is consistent with data on early worsening of pre-existing retinopathy after glycemic control improves. While FDA's ophthalmology consultant concludes there's no cause for worry, clinical review team expresses 'residual concerns.'
In an interview, Spark President Katherine High explains that multi-luminance mobility test used in clinical development of Spark's gene therapy voretigene sprang from 2011 FDA meeting on need to study functional vision in patients with retinal degenerative diseases. Experience highlights need for new endpoints when targeting previously untreated diseases, she says.
Improvements seen in multi-luminance mobility testing in the voretigene Phase III trial were clinically meaningful, panelists said, endorsing the novel endpoint for the vision loss treatment. They also were persuaded by first-hand accounts from patients.
Multi-luminance mobility testing was developed by firm to measure functional vision across a range of lighting levels in patients with RPE65 mutations; advisory committee also will consider minimum patient age and clinical stage of disease appropriate for subretinal injections with voretigene.
Appeals court vacates injunction that Repatha marketer Amgen had won against Sanofi/Regeneron's Praluent, but notes 'a reduction in choice of drugs cannot be the sole reason for a district court to deny an injunction.'