FDA Approves Pierre Fabre's Hemangeol For Infantile Hemangioma
By Cyndi Root
Pierre Fabre Dermatologie announced in a press release that the Food and Drug Administration (FDA) has approved Hemangeol (propranolol hydrochloride). The pediatric drug treats proliferating infantile hemangioma (IH) requiring systemic therapy. The oral solution will be available in June of 2014. Dr. Christine Léauté-Labreze, a dermatologist at the Bordeaux University Hospital, first discovered the efficacy of propranolol for this condition in 2007. Dr. Jean-Jacques Voisard, Dermatologist and General Manager of Pierre Fabre Dermatologie, said, “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.”
Infantile Hemangiomas
A common vascular tumor in infancy, IH affects about 3 to 10% of newborns. Tumors are benign, diagnosed by excess endothelial tissue. Hemangiomas do not hurt the child unless they are in a vulnerable area such as the diaper area or near the eyes, mouth, nose, and ears. Sometimes they bleed, but they are harmless. About 12% need treatment due to obstructed airways, disfigurement, or cardiovascular concerns. Treatment with beta-blockers is common but other options include glucocorticosteroids and laser therapy.
Hemangeol
Hemangeol (propranolol) is a beta blocker. The drug has been used in cardiology for some time, but its effects on IH had never been studied until Dr. Léauté-Labreze discovered its potential. Pierre Fabre Dermatologie took an interest in the drug in 2009 and commenced studies of the drug’s profile and its effect in clinical trials. The company partnered with Dr. Léauté-Labreze of Bordeaux University Hospital and Aquitaine Science Transfert to develop the drug for IH. Pierre Fabre submitted the New Drug Application (NDA) to the FDA in May of 2013. The company submitted an application to the European Medicines Agency and approval is expected at the end of April of this year.
About Pierre Fabre
Pierre Fabre is a uniquely structured company dedicated to carry out the vision of its founder, pharmacist Pierre Fabre. The structure of the company helps ensure the continuity of the company. The Pierre Fabre Foundation is the major shareholder, a public interest organization recognized by the French government. Minority shareholders include employees. The FDA recently approved another of the company’s drugs, Fetzima (levomilnacipran), a serotonin and norepinephrine reuptake inhibitor (SNRI) indicated for Major Depression.