Kigabeq® becomes the fourth human medicine to be granted a Pediatric Use Medicine Authorization (PUMA) in Europe
Friedrichsdorf/Mannheim, Germany – October 25th 2018: PharmaLex Group, one of the largest and most successful specialist providers of Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance, Epidemiology and Risk Management worldwide, is proud to announce that the European Commission has adopted the CHMP decision for Kigabeq® – vigabatrin; granting of Pediatric Use Marketing Authorization (PUMA) for ORPHELIA Pharma SAS – a biopharmaceutical company based in Paris and Lyon.
PharmaLex has provided ORPHELIA Pharma SAS with various regulatory activities in relation to the preparation, submission and coordination of this successful marketing authorization via the Centralized Procedure (CP) for Kigabeq®.
Kigabeq® is the first pediatric formulation of the antiepileptic drug, vigabatrin. It has been exclusively developed for young children (1 – 7 years) and will therefore, benefit from a Pediatric Use Marketing Authorization (PUMA). Kigabeq® is the fourth human medicinal product to be granted a PUMA in the EU.
“We have been working in close cooperation with PharmaLex on the Kigabeq® marketing authorization dossier”, explained Hugues Bienaymé, General Manager of ORPHELIA Pharma. “They have done a tremendous job, all the way from the initial eligibility request, to the final European Commission decision. The whole process went smoothly and the level of support and guidance was very high”, he added. “This was a challenging project and its success is a result of the high motivation and effort from every member of the intercompany team”, explained Dr. Laura Boteanu-Jotzu, Director, Head of Regulatory Affairs Team, PharmaLex. “The trusted partnership between ORPHELIA Pharma and PharmaLex, alongside the shared willingness to reach the objective of Kigabeq® resulted in the granting of this PUMA”, added Dr. Thomas Dobmeyer, CEO, PharmaLex.
About ORPHELIA Pharma SAS
ORPHELIA Pharma SAS is a biopharmaceutical company dedicated to the development and marketing of pediatric drugs in oncology and neurology. Their mission is to provide meaningful advances to children through the development of efficient, reliable and easy-to-use medicines. Our projects are focused on the development of novel pediatric formulations of approved drugs, approved drugs in new pediatric indications and new drugs in pediatric orphan or ultra-orphan indications.
About PharmaLex <Confidence beyond compliance>:
PharmaLex is one of the largest providers for Development Consulting, Regulatory Affairs, Quality Management & Compliance and Pharmacovigilance worldwide. Our global teams of experts can take you through early strategic planning activities and nonclinical requirements to clinical development, through regulatory submission processes and finally guide you to market approval and product maintenance post-launch activities. We strive to deliver exceptional results — going above and beyond the standard to deliver tailor-made solutions. We aim to exceed your expectations and live by our values – flexibility, efficiency, passion & dedication.
The PharmaLex Group now has over 750 employees, with 31 offices in 17 countries and more than 600 satisfied clients worldwide.
For further information, please contact:
Ms. Eva Keck
PharmaLex GmbH; Director, Business Development Operations
+49 621 18 15 38 0
Harrlachweg 6; 68163 Mannheim