FDA Review Panel For Cornerstone’s Lixivaptan To Consider Safety Of Outpatient Initiation
This article was originally published in The Pink Sheet Daily
The Cardiovascular and Renal Drugs Advisory Committee will face a choice between an agency reviewer’s cautious approach to titration and the sponsor’s push for easier access to the hyponatremia drug.
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The hyponatremia drug is a selective vasopressin V2-receptor antagonist, like Astellas’ Vaprisol and Otsuka’s Samsca.
Industry also seems supportive of the idea, while Pew touts the power of the power of track-and-trace as a deterrent.
EMD Serono has been tracking Serostim packages since 2002; J&J is using Prezista 600 mg as a trial run for serialization.