Pierre Fabre Dermatologie has received FDA marketing approval of Hemangeol (propranolol HCl) oral solution for the treatment of proliferating infantile hemangioma requiring systemic therapy.
Hemangeol was studied in a randomized, double-blind, placebo-controlled, multi-dose and multi-center adaptive Phase 2/3 trial in infants 5 weeks–5 months old. Four propranolol treatment regimens were compared (1 or 3mg/kg/day for 3 or 6 months) vs. placebo. Results showed that the 3mg/kg/day for 6 months treatment group had a 60.4% success rate vs. 3.6% in the placebo group (P<0.0001). It met the primary endpoint of complete or nearly-complete resolution of the target hemangioma.
Propranolol HCl was used off-label as the first-line treatment for infantile hemangioma since 2007. While commonly used in cardiology, the use of propranolol in infants was never properly evaluated and there were no formulations approved for pediatric use. Propranolol HCl is a noncardioselective beta-blocker that is currently approved for various cardiovascular diseases including angina, hypertension, arrhythmias, and as migraine prophylaxis.
Hemangeol oral solution will be available in June 2014.
For more information call (800) 678-1605 or visit Pierre-Fabre.com.