FDA approves Hemangeol for infantile Haemangioma - Pierre Fabre

The FDA has approved Hemangeol (propranolol hydrochloride), from Pierre Fabre, as treatment for �proliferating infantile Haemangioma requiring systemic therapy�. Hemangeol is an oral solution specially developed for safe and effective use in children. Hemangeol will be available in the US in June 2014. The treatment was submitted to the EMA in 2014 and recommended by the CHMP in February. Final approval is expected in April 2014.

FDA approval was based on studies in infants 5 weeks to 5 months old with a proliferative infantile Haemangioma requiring systemic treatment. These randomized, double blind placebo controlled, multi-dose and multi-center adaptive Phase II/III trials compared four propranolol treatment protocols (1 or 3 mg/kg/day for 3 or 6 months) versus placebo. The treatment protocol of 3 mg/kg/day dose for the duration of 6 months had a 60.4% success rate versus 3.6% in the placebo group reaching the primary endpoint: complete or nearly-complete resolution of the target hemangioma. In 11.4% of patients needed to be retreated after stopping the treatment.