EC approves Merck KGaA's Pergoveris

Darmstadt, Germany-based Merck KGaA says that the European Commission has granted a marketing authorization for Pergoveris for the stimulation of follicular development in women with severe luteinizing hormone and follicle stimulating hormone deficiency. The agent is the first biotechnology product based on the combination of recombinant human FSH (r-hFSH or follitropin alfa 150IU) and recombinant human LH (r-hLH or lutropin alfa 75IU), which allows administration of both substances in a single subcutaneous injection. The European Commission decision applies to all 27 countries in the European Union, as well as Iceland, Liechtenstein and Norway. Pergoveris will be launched in the various EU countries in the current quarter.