Redux Approved In The USA; Launch In June

Interneuron shares rose sharply last week on the news that it had received approval from the US Food and Drug Administration for Redux (dexfenfluramine), a new treatment for obesity.

Dexfenfluramine has been available in more than 65 countries for the past decade, but concerns about adverse events with long-term use held up its approval in the USA. It finally got an advisory panel backing (by a slim margin) towards the end of last year (Marketletter November 29, 1995). Several meetings with the committee were required before the company convinced them that the efficacy and safety of dexfenfluramine supported its use for obesity.

The FDA approval includes an indication for weight loss and maintenance of weight loss in patients who are already on a reduced-calorie diet. Interneuron notes that the drug will be launched in June and should cost around $2 per day.