Interneuron's CerAxon To Be Fast-Tracked

The US Food and Drug Administration has designated Interneuron'sCerAxon (citicoline) as a "fast-track" drug for the treatment of ischemic stroke. CerAxon had previously received priority review status - meaning that it must be reviewed by the agency within six months from the filing date.

Designation as a fast-track drug also means that the FDA considers CerAxon to be intended for a serious or life-threatening condition that currently has an unmet medical need, and could result in the FDA taking action to speed up its development and review. A New Drug Application was filed with the US regulatory authorities late last year (Marketletter December 22, 1997).

Analysts have estimated that CerAxon will have sales of $300-$400 million annually, which will provide a welcome boost for the company which suffered last year following the discontinuation of the antiobesity drug Redux (dexfenfluramine; Marketletters passim).