FDAnews Drug Daily Bulletin
Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

Hemangiol Scores EMA’s Second Positive PUMA Opinion

Feb. 24, 2014
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The European Medicines Agency (EMA) has approved a second pediatric-use marketing authorization (PUMA), making way for Pierre Fabre’s Hemangiol to be used in the treatment of proliferating infantile haemangioma.

This is the second time the EMA’s Committee for Medicinal Products for Human use has granted a positive opinion for a PUMA since the program was introduced in 2007. The first PUMA was granted in 2011 to ViroPharma’s Buccolam (midazolam) for the treatment of prolonged, acute convulsive seizures in pediatric patients between the ages of three months to 18 years.

Infantile haemangioma are benign tumors due to the buildup of blood vessels in the skin or internal organs that typically develop in the first six weeks after birth. Although usually uncomplicated, haemangioma can produce painful ulcerations and scarring — and in rare cases, life-threatening complications such as breathing difficulties and heart problems, the EMA says.

Currently, throughout most of Europe there are no approved treatment options, although corticosteroids are authorized for severe cases in France and Germany, the agency notes.

PUMAs can be granted for medicines which are already authorized, but no longer under patent protection, and that have been developed specifically for children. Applicants must first develop a pediatric investigation plan detailing the drug’s evaluation in children and has to be approved by EMA’s Pediatric Committee. — Nick Otto

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