FDA Approves Serostim For AIDS Wasting

Ares-Serono's recombinant human growth hormone product Serostim has been cleared for marketing in the USA for AIDS wasting or cachexia. The approval came despite the submission being narrowly voted down by an advisory committee back in March (Marketletter March 11), which asked the company to provide more data to identify which patient subgroups might best respond to therapy with the drug.

The firm has agreed to slash the price of the drug by half after prompting from AIDS activists, according to the Wall Street Journal, and this is thought to have played a key role in securing approval. Serostim has already been used by several hundred patients with AIDS in the USA under a compassionate-use program.

The FDA's approval letter notes that Serono has agreed to conduct Phase IV studies, in particular a trial in which patients' physical function will be measured using a treadmill. In the trials which supported the application, Serostim improved lean body mass but had no effect on survival compared to placebo.