First EMEA Approval Is For Serono's Gonal-F

The first product to be approved by the London, UK-based European Medicines Evaluation Agency under the new centralized procedure is Ares-Serono's Gonal-F (recombinant human follicle-stimulating hormone), a treatment for infertility. Serono now holds a single commercial license allowing marketing of the drug in all 15 member states of the European Union.

Gonal-F was approved in Sweden and Finland, and was recommended for approval in Switzerland, in 1994. The drug, which is the first recombinant drug for the treatment of infertility in the EU, is indicated to stimulate the development of ovarian follicles in women undergoing assisted reproduction techniques. Serono now plans to introduce the product in several European markets by the end of this year or early 1996.

Gonal-F is the first in a new generation of recombinant hormones intended to replace Serono's natural-source products. These urine-derived drugs are efficacious but raise the question of protein contaminants causing side effects. The other recombinant products are LHadi (luteinizing hormone) and Ovidrel (chorionic gonadotrophin), both of which are still in trials. Gonal-F is also pending approval in the USA, where it is currently under review.