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Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

FDA Approves Pierre Fabre’s Hemangeol for Infantile Hemangioma

March 19, 2014
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Pierre Fabre has received FDA approval for its oral drug Hemangeol, indicated to treat proliferating infantile hemangioma (IH) requiring systemic therapy. This is the first and only approved treatment for this type of IH, the French drugmaker said Monday.

Hemangeol (propranolol hydrochloride) has long been used to control atrial and ventricular arrhythmias. The drug had become the off-label treatment for IH, according to Pierre Fabre, though no formal studies had ever been conducted on children.

In 2009, the company conducted a randomized, double-blind, placebo-controlled, multi-dose and multi-center Phase II/III trial of infants ages 5 weeks to 5 months that compared four Hemangeol treatment protocols to placebo. Results showed that infants in the 3 mg/kg/day dosing arm had a 60.4 percent success rate over six months compared with only 3.6 percent of patients on placebo.

The drug will be available to U.S. infants by June. Hemangeol also received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use on Feb. 21. EU marketing authorization is expected by Apr. 28, Pierre Fabre says.

The drugmaker is focused in dermatology, neuropsychiatry and oncology. In July, the FDA approved Fetzima (levomilnacipran extended-release capsules), a once-daily serotonin and norepinephrine reuptake inhibitor developed by Pierre Fabre and Forest Labs. — Lena Freund

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