With this approval, Pergoveris® becomes the first product with a combination of FSH and LH hormonesin aready-to-use liquid version
The newpre-filledinjection device for self-administration increases ease-of-use forpatientscompared to the vial form
Merck, a leading science and technology company, today 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 European approval of our new Pergoveris® Pen is a step towards fulfilling our commitment of improving treatment outcomes for couples aspiring to become parents," said Luciano Rossetti, Global Head of Research and Development at the biopharma business of Merck. "We strive for continual innovation of our products for the benefit of our patients, and our new Pergoveris® Pen enables us to provide women and couples with an improved patient experience during their treatment journey."
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™.
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.
The Family of Pens™
The Family of Pens™ consists of prefilled ready-to-use pens for GONAL-f® 300 IU, 450 IU, and 900 IU, and OVITRELLE®/OVIDREL® 250 mcg and now includes the Pergoveris® Pen 300IU, 450IU and 900IU. The Family of Pens™ was developed based on feedback from healthcare professionals and those experiencing fertility problems to provide a common injection solution for Merck's gonadotropins, in order to ease the teaching, learning and use of the pens.
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Merck is a leading science and technology company in healthcare, life science and performance materials. Around 50,000 employees work to further develop technologies that improve and enhance life - from biopharmaceutical therapies to treat cancer or multiple sclerosis, cutting-edge systems for scientific research and production, to liquid crystals for smartphones and LCD televisions. In 2016, Merck generated sales of € 15.0 billion in 66 countries.
Founded in 1668, Merck is the world's oldest pharmaceutical and chemical company. The founding family remains the majority owner of the publicly listed corporate group. The company holds the global rights to the Merck name and brand. The only exceptions are the United States and Canada, where the company operates as EMD Serono, MilliporeSigma and EMD Performance Materials.
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