Pierre Fabre's Hemangeol Approved For Infantile Hemangioma

The U.S. Food and Drug Administration (FDA) has granted approval for Pierre Fabre for its oral drug Hemangeol (propranolol hydrochloride) for the treatment of proliferating infantile hemangioma (IH) necessitating systemic therapy. The French drugmaker said that Hemangeol is the first and currently only approved treatment for the IH disease type.

Bertrand Parmentier, CEO of Pierre Fabre Laboratories, said, “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.”

Hemangeol is currently used in the management of atrial and ventricular arrhythmias. However, Pierre Fabre said that the drug has become the off label treatment for IH despite the lack of formal studies on children.

The company conducted a randomized, placebo controlled, multi-dose, multi-center, and double blind Phase II/III study in 2009 on infants ages five weeks to five months. The trial compared four Hemangeol treatment protocols to placebo. Study results showed that infants in the 3 mg/kg/day dosing treatment arm recorded a 60.4% success rate over the course of six months against only 3.6% of patients taking placebo.

Laurent-Emmanuel Saffré, General Manager of Pierre Fabre Pharmaceuticals, Inc. in the U.S., said, “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.”

The drug has recently received a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP). Hemangeol is expected to win EU marketing approval next month and to launch in the U.S. by June.