First Approval Of Geref As Therapeutic

Ares-Serono rounded off a busy week with the approval in the USA ofGeref (sermorelin acetate for injection), its growth hormone-releasing hormone, which is indicated for the treatment of growth hormone deficiency in children with growth failure. The Geref approval comes hot on the heels of US approval for Serono's Gonal-F (follitropin alfa; see below) for infertility and Phase III data on its interferon beta-1a drug Rebif for multiple sclerosis (see page 19).

Serono told the Marketletter that this is the first approval of the product as a therapeutic, and that it is the first company to offer two approaches to treating this growth hormone deficiency. Geref has been available since 1990 in the USA as a diagnostic used to determine growth hormone function. The company expects to launch Geref as a therapeutic in the USA in early 1998.

As a condition of approval, Serono has agreed to conduct Phase IV dose-optimization studies investigating the total daily dose of Geref with regard to its efficacy.