Merck KGaA says that the European Commission granted marketing authorisation for its infertility treatment Pergoveris and the firm has also received a recommendation to sell a new formulation of Rebif to treat relapsing multiple sclerosis.
The German firm’s biopharmaceutical unit Merck Serono said that Pergoveris (follitropin alfa/lutropin alfa) has been approved for the stimulation of follicular development in women with severe luteinising hormone (LH) and follicle stimulating hormone (FSH) deficiency. The EC’s decision applies to all 27 countries in the European Union, as well as Iceland, Liechtenstein and Norway, and launches will start taking place in the third quarter of 2007.
Hans Christian Rohde, head of reproductive health at Merck Serono, said the approval “is good news for infertile women in Europe who have severe endogenous FSH and LH deficiencies", noting that Pergoveris is the only fertility treatment “which combines the benefits of two consistent and pure recombinant products”.
Rebif recommended in new formulation
The decision comes a day after the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommended marketing authorisation of a new formulation of Merck Serono’s best-selling Rebif (interferon beta-1a) to treat relapsing multiple sclerosis.
The CHMP's recommendation is based on a Phase III study which showed that the new formulation leads to a rate of injection-site reactions in MS patients treated with Rebif over one year that is three times lower, compared with historical data from previous trials. The firm added that the new formulation has been developed in the same strengths and pharmaceutical forms as currently registered (8.8, 22 and 44 mcg) as a solution for injection in pre-filled syringes and “originates from an innovative approach, using state-of-the-art technologies”.