First approval of Asta's cetrorelix in EU

The European Medicines Evaluation Agency has issued a MarketingAuthorization for Asta Medica's Cetrotide (cetrorelix acetate) for the prevention of premature ovulation in patients undergoing controlled ovarian stimulation, followed by oocyte pick-up and assisted reproduction. This is the first approval for the drug, which acts as a luteinizing hormone-releasing hormone (LHRH) antagonist.

The first launches of Cetrotide, which is the first drug acting via this mechanism to be registered, will take place in Germany and the UK this month, Asta will market the drug with copromotion from Ares-Serono, the leading company in infertility treatment, under the terms of an agreement between the two firms which was signed at the end of last year (Marketletter December 14, 1998).

The drug will be marketed as an alternative to LHRH agonists, which cause an initial surge in LH activity followed by down-regulation of LH receptors. As an antagonist, cetrorelix provides an immediate suppression of LH activity, without an initial stimulatory effect, and this allows a shorter, more convenient and safer way of controlling endogenous LH, notes Asta. Premature ovulation can be avoided using either one 3mg dose or a series of 0.25mg doses of the product.