Products

beta-blocker/antiinflammatory agent. Propranolol is a beta-blocking agent. Potential mechanisms of action of propranolol in proliferating infantile haemangioma could include various mechanisms all in close relationship (a local haemodynamic effect, an antiangiogenic effect, an apoptosis-triggering effect on capillary endothelial cells or a reduction of both VEGF and bFGF signalling pathways). The efficacy of propranolol in the treatment of infantile hemangioma was first discovered in 2007 by Dr. Christine Léauté-Labreze, a dermatologist at the Bordeaux University Hospital. Subsequently, the off-label use of this molecule became the first-line treatment for infantile hemangioma. While propranolol has long been known and used in cardiology, its use in infants with infantile hemangioma had never been properly studied and there was no pharmaceutical form approved for pediatric use. In 2009, Pierre Fabre Dermatologie undertook the pharmaceutical and clinical development required to make the Bordeaux University Hospital discovery accessible to infants with infantile hemangiom, with proven clinical safety and efficacy.

• • On May 5, 2014, Pierre Fabre Dermatologie Laboratories have 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”. 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 FDA* approval obtained on March 14th for Hemangeol™, the trade name of the identical drug to be launched on in the US in June. This PUMA (Paediatric Use Marketing Authorization) is only the second of its type, for all pathologies, that the European Medicines Agency (EMA) has issued since the system was established in 2007.
• • On March 17, 2014, Pierre Fabre Dermatologie has obtained marketing authorization from the FDA for the pediatric drug Hemangeol® (propranolol hydrochloride), which is the first and only approved treatment for “proliferating infantile hemangioma requiring systemic therapy”. Hemangeol® will be available June 2014. This marketing authorization comes after the new drug application for Hemangeol was submitted to the US FDA in May 2013. The application was also submitted to the European Medicines Agency, receiving positive opinion on February 21st, 2014 from the CHMP, with marketing authorization expected for April 28th, 2014. “The marketing authorization granted by the FDA rewards a public–private partnership developed over the last six years by Pierre Fabre Laboratories and the Bordeaux University Hospital, with the support from Aquitaine Science Transfert,”stated Eric Ducournau, CEO of Pierre Fabre Dermo-cosmetics SAS, parent company of Pierre Fabre Dermatologie.
• • On February 20, 2014, the Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion, recommending the granting of a marketing authorisation for Hemangiol®, 3.75mg/ml, oral solution intended for the treatment of proliferating infantile haemangioma requiring systemic therapy. The benefits with Hemangiol® are its ability to result in a complete or nearly complete resolution of the target haemangioma, which was evaluated by blinded centralised independent assessments made on photographs at Week 24. The most common side effects are sleep disorders, aggravated respiratory tract infections such as bronchitis and bronchiolitis associated with cough and fever, diarrhoea, and vomiting. A pharmacovigilance plan for Hemangiol® will be implemented as part of the marketing authorisation.