Regulators in Europe have given the green light to Pierre Fabre’s Hemangiol for the treatment of proliferating infantile haemangioma.
The European Commission has granted the French company authorisation to market Hemangiol, an oral solution of the beta-blocker propranolol specially developed for paediatric use. The thumbs-up follows an approval in the USA in March; it will be launched across the Atlantic as Hemangeol next month.
The approval this side of the pond is a Paediatric Use Marketing Authorisation, only the second of its type that the European Medicines Agency has issued since the system was established in 2007; the first PUMA was granted in 2011 to ViroPharma’s anti-seizure drug Buccolam (midazolam).
Infantile haemangioma (also known as strawberry birthmarks) caused by abnormal blood vessels in or under the skin. The efficacy of propranolol for this condition was first discovered in 2007 by Christine Leaute-Labreze at Bordeaux University, who noted that 12% of haemangiomas are severe forms that can lead to complications such as airway obstruction, vision problems or irreversible disfigurement.
However, there was no treatment available “that offered adequate efficacy and tolerance”, she added, noting that the approval “provides a legal framework that protects the child, family members and the prescribing practitioner”.
In 2009, Pierre Fabre Dermatologie and the University of Bordeaux had formed a partnership to make this discovery available to infants with infantile hemangioma (IT) under conditions specifically adapted to pediatric use.
Hemangiol will be launched firstly in France and Germany, and gradually throughout other European markets.
