Veloxis' Tacrolimus Clears FDA For Narrower Population Following Court Loss
This article was originally published in The Pink Sheet Daily
Envarsus XR, a once-daily version of the immunosuppressant, is approved for kidney transplant patients seeking to convert from twice-daily formulations; a claim for use in newly transplanted, 'de novo' patients was blocked by Astellas' three-year exclusivity on Astagraf.
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A roundup of the US FDA's drug approvals in the final weeks of 2018.
US FDA Panel Rejects Pfizer's Broad COVID Booster Plan But Backs Narrower Authorization For Third Vaccine Shot
Advisory committee meeting reflected internal tensions among FDA staff on need for boosters and adequacy of the data; mRNA vaccine Comirnaty should be authorized for a third dose in populations at high risk for severe disease or exposure, panel says after overwhelmingly rejecting Pfizer's bid for booster approval in the 16-and-older population.
If regulators agree with Pfizer’s conclusions – and briefing documents suggest that’s a big if – about real-world studies showing Comirnaty’s effectiveness waning over time, thereby justifying the need for a booster dose, it could be part of a historical moment for FDA’s use of RWE.