Eylea Label For Retinopathy Of Prematurity Should Specify ‘Treatment Tradeoff’ Versus Laser
US FDA advisory committee recommends ‘more granularity’ in label on administration of Eylea in premature infants. Specifying intervals between injections is important for insurance coverage, agency official notes.
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Two studies failed to demonstrate that Eylea was non-inferior to laser treatment. Agency says compared to the expected natural history, there is a ‘clear beneficial effect’ of Eylea which also maintains peripheral vision. Advisory committee to discuss how to convey findings in label.
Delaware district judge rules against AstraZeneca’s claim the IRA violates its due process rights, echoing findings made by Ohio district judge in Chamber of Commerce’s suit. Only other IRA ruling to date dismissed PhRMA’s complaint on procedural grounds without addressing the merits.
Agency anticipated receiving more applications for the program, which aims to bring Operation Warp Speed-like response to investigational rare disease therapies, than it has so far, though a last-minute ‘flood’ is still expected. CBER and CDER are accepting requests through 1 March.