EU approval for Ares-Serono's Gonal-F

Ares-Serono has received approval from the European Union to market itsrecombinant human follicle stimulating hormone Gonal-F (follitropin alfa) for hypogonadotrophic hypogonadism, a new indication. The European Medicines Evaluation Agency also backed a labeling change for the product to include a statement highlighting the product's efficacy over urine-derived FSH products.

The EMEA additionally granted marketing clearance for Gonal-F 37.5 IU, a new strength tailored for use in ovulation induction therapy; the product is already available in doses of 75 IU and 150 IU.

Clinical trials have shown that Gonal-F results in a greater production of oocytes and embryos compared to urinary FSH products. A spokeswoman for the company told the Marketletter that while Gonal-F had a similar dosing regimen to conventional treatment, three 150IU injections per week for up to 18 months, it offered a higher level of purity, reduced side effects (including no local reactions) and greater potency.