Yamanouchi's Vaprisol Goes To Advisory Committee Sept. 9 As First Hyponatremia Drug
This article was originally published in The Pink Sheet Daily
Executive Summary
The company estimates 1% to 6% of hospitalized patients have the electrolyte disorder, also known as water poisoning. Conivaptan was eligible for priority review, but the firm opted for a 10-month clock to allow time for an advisory committee review.
You may also be interested in...
Astellas’ Vaprisol Approved For “Water Poisoning” Indication
Arginine vasopressin antagonist is the first drug indicated for the treatment of euvolemic hyponatremia.
Astellas’ Vaprisol Approved For “Water Poisoning” Indication
Arginine vasopressin antagonist is the first drug indicated for the treatment of euvolemic hyponatremia.
Yamanouchi Vaprisol “Approvable” Letter Requests Additional Safety Data
Discussions with FDA are ongoing but there is no timeframe for submission of a complete response, Yamanouchi says. Conivaptan would be first hyponatremia drug.