Pierre Fabre gains EU approval for Hemangiol, for proliferating infantile hemangioma

French drugmaker Pierre Fabre Dermatologie Laboratories has obtained European Commission authorization to market Hemangiol (propranolol), the first and only drug to be approved for the treatment of proliferating infantile hemangioma requiring systemic treatment, the company said.

Hemangiol is an oral solution specially developed for pediatric use. It will be launched firstly in France and Germany, and gradually throughout other European markets. This European agreement follows the US Food and Drug Administration approval obtained for the same product but under the Hemangeol brand name (The Pharma Letter March 18); a launch in the USA is set for June.

This PUMA (Pediatric Use Marketing Authorization) is only the second of its type, for all pathologies, that the European Medicines Agency has issued since the system was established in 2007.