US Launch Of Ares-Serono's Geref As Therapeutic

Ares-Serono has launched its growth hormone releasing hormone Geref(sermorelin acetate for injection) in the USA as a therapy for idiopathic growth hormone deficiency in children. This is the first launch of the product for this indication.

Geref has been available in the USA as a diagnostic for growth disorders since 1990. It was approved as a therapy last year on the condition that A-S agreed to conduct Phase IV dose-optimization studies to evaluate the total daily dose of Geref with regard to its efficacy (Marketletter October 13, 1997).

GHD is a consequence of either abnormally low levels of pituitary human growth hormone or of a biochemical malfunction whereby GHRH fails to spark the release of hGH from the pituitary. In the latter situation, children may have untapped reserves of hGH, says the company, which added that Geref triggers the release of these reserves in order that they can then be used by the body. GHD is conventionally treated with a recombinant hGH product.