Redux Clears Advisory Panel By Narrow Margin

After several attempts, Interneuron has fnally managed to secure an approval recommendation from the US Food and Drug Administration's Endocrinologic & Metabolic Drugs Advisory Committee for its Redux (dexfenfluramine) antiobesity drug. If the FDA now grants the product full approval, it will become the first new weight loss drug to reach the market in the USA in over 20 years.

Nevertheless, the recommendation was only given by the narrowest of margins (six votes in favor versus five votes against). The efficacy of the drug was not in question and had been discussed at a previous meeting on September 28 (see Marketletter October 9). At that time no decision on the drug was taken, largely because of safety concerns, raised by the FDA, that it might cause morphological changes and/or serotonin depletion. As data on this issue were not available, a November 16 panel meeting was scheduled to discuss the matter further.

No Evidence For Neurotoxicity To address the FDA's concerns, Interneuron submitted data from an 18-month, 72-patient study which found that treatment with dexfenfluramine at the recommended dose (15mg bd, for six months) did not adversely affect mood, depressive symptoms or cognitive function compared to placebo, either during treatment or after it was discontinued. This was accepted by the FDA's medical reviewer, but other members of the panel questioned the validity of the data given the small sample size, and there were suggestions that measurements of cognitive function may not have been sufficiently robust.