Dermatology: Pierre Fabre obtains FDA Approval to market Hemangeol TM
March 17, 2014
Pierre Fabre Dermatologie has obtained marketing authorization from the FDA* for the pediatric drug HemangeolTM (propranolol hydrochloride), which is the first and only approved treatment for “proliferating infantile hemangioma requiring systemic therapy”. Hemangeolis an oral solution specially developed for safe and effective use in children. 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 efficacy of propranolol in the treatment of infantile hemangioma (IH) 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 IH. While propranolol has long been known and used in cardiology, its use in infants with IH 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 IH, with proven clinical safety and efficacy.
This collaboration has endowed pediatric dermatology with a new therapy that fulfills an unmet medical need and thousands of American children may now benefit from this new therapy each year, declared Dr. Jean-Jacques Voisard, Dermatologist, General Manager of Pierre Fabre Dermatologie.
As Pierre Fabre US representatives we are proud to be part of a Group able to develop children dedicated medicines and to be the first Pierre Fabre subsidiary to obtain marketing approval for Hemangeol, underlined Laurent-Emmanuel Saffré, General Manager of Pierre Fabre Pharmaceuticals, Inc. (USA).
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.
Following the marketing authorization approved by the FDA in July last year for Fetzima (levomilnacipran extended-release capsules), a drug created by Pierre Fabre research and developed in partnership with Forest Laboratories, the Hemangeol marketing authorization is yet further recognition for our R&D on the world’s most demanding pharmaceutical market. This is a tremendous encouragement to pursue our R&D effort in oncology, dermatology and neuropsychiatry which are our prioritized therapeutic areas of innovation,commented Bertrand Parmentier, CEO of the Pierre Fabre Laboratories.
About infantile hemangiomas
Infantile hemangioma is the most common vascular benign tumor of infancy, affecting 3% to 10% of newborns. This benign tumor is characterized by abnormal proliferation of the endothelial tissue. The lesions are rarely detectable at birth and start growing noticeably during the first 4 to 6 weeks of life. While most infantile hemangiomas do not require treatment, approximately 12% require treatment. Some infantile hemangiomas based on their location can be functionally impairing (breathing, eating, vision) or life-threatening. Ulceration is the most common complication (with incidence of 16%). Other major complications are airway obstruction, cardiovascular risk or permanent disfigurement.For more information, visit www.infantilehemangioma.com
* FDA (Food and Drug Administration)
** CHMP (Committee for Medicinal Products for Human Use)