EU approves new Pergoveris Pen a ready-to-use fertility combination treatment option for women with severe follicle stimulating hormone and luteinizing hormone deficiency.- Merck KgAA

Merck KgAA, has announced that the European Commission has granted approval for the new Pergoveris Pen, addressing an unmet medical need by providing an improved, convenient and ready-to-use fertility combination treatment option for women with severe follicle stimulating hormone (FSH) and luteinizing hormone (LH) deficiency.

The new liquid version of Pergoveris was created by evolving the original freeze-dried powder and solvent combination � which required patients to mix the product vials themselves before daily injection � towards a ready-to-use pre-filled Pen solution. By eliminating the need for mixing, the new Pergoveris Pen allows an improved treatment experience for patients with severe follicle stimulating FSH and LH deficiency.

The new Pergoveris Pen is the only premixed combination of human FSH (hFSH) and human LH (hLH) on the European market available in a pre-filled injection device for self-administration. Designed with feedback from patients and healthcare professionals in mind, the Pergoveris Pen enables physicians to individualize the dosing to patient�s needs, by allowing for 12.5 IU increments and offering three strengths: 300IU, 450IU and 900IU. The Pergoveris� Pen is the third addition to Merck�s innovative delivery solution Family of Pens�.

Comment: Pergoveris is the first combined product of recombinant human follicle stimulating hormone (r-hFSH or follitropin alfa 150 IU) and recombinant human luteinizing hormone (r-hLH or lutropin alfa 75 IU). It is unique by combining the benefits of two consistent and pure recombinant products, r-hFSH and r-hLH, for the treatment of infertility in specific indications. Pergoveris is indicated for the stimulation of follicular development in adult women with severe luteinizing hormone (LH) and follicle stimulating hormone (FSH) deficiency.