Serostim Turned Down By US Committee

Ares-Serono has failed to secure the backing of a US Food and Drug Administration advisory committee in its bid to gain approval to market Serostim (recombinant human growth hormone) for AIDS wasting.

A joint panel voted eight against and seven in favor of full approval at a meeting on March 1. The reason for the split seemed to lie with the endpoints of one of the Phase III studies submitted by Serono in support of the marketing application.

These endpoints were decided upon on the basis of current medical thinking at the outset of the studies, over four years ago. One of the studies looked at overall weight gain and lean body mass in its protocol, while the other looked at overall weight gain only. "Since then it has become apparent that an increase in lean body mass is far more predictive of a reversal of AIDS wasting...and leads to increased strength, endurance and overall quality of life," commented the company.