Samska worth its salt

An FDA panel decided last week that the clinical reality of treating patients with hyponatremia trumped a lack of clearly defined clinical benefit on a subjective scale for Samska tolvaptan from Otsuka Pharmaceutical Co. Ltd. As a result, the Cardiovascular and Renal Drugs Advisory Committee voted 8-3 to recommend approval of Samska for chronic oral treatment of hypervolemic or euvolemic hyponatremia, a condition that may be characterized by signs of mental deficit, among other symptoms.

The panel’s discussion centered on whether low serum sodium is a biomarker for underlying disease or is a modifiable clinical condition in its own right. If the latter, the question became what clinical benefits can be measured as a consequence of improving hyponatremia...