Pierre Fabre wins FDA approval for infantile hemangioma drug

Pierre Fabre has been granted approval by the US Food and Drug Administration (FDA) to market propranolol hydrochloride as a treatment for proliferating infantile hemangioma.

The drug, which is sold under the brand name Hemangeol, becomes the only therapy indicated for the condition, which is characterised by benign tumours that manifest in the first few weeks of life.

It will be available from June this year as an oral solution, developed specifically for safe and effective application in young children.

Pierre Fabre originally submitted Hemangeol to the FDA in May 2013. It filed an application with the European Medicines Agency at the same time, receiving positive opinion on February 21st 2014. The company expects marketing authorisation in Europe by April 28th.

Commenting on the FDA approval, 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."