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The European Medicines Agency (EMA) has recommended granting pediatric use marketing authorization (PUMA) for Bopediat (furosemide, Proveca Pharma Limited) to treat children younger than 18 years with edema of cardiac, renal, or hepatic origin.
The agency also recommends PUMA for treating hypertension in children with chronic kidney disease.
Bopediat contains the same active ingredient as Lasilix Faible 20-mg tablets, which have been authorized in France since April 1977 for the same indications. The key difference is that Bopediat will be available at a lower strength of 5 mg as orodispersible tablets for easier administration in children.
Furosemide is a loop diuretic that mainly works on the thick ascending limb of the loop of Henle and on the proximal and distal tubules of the kidney, where it inhibits reabsorption of sodium chloride. This leads to excessive excretion of water, sodium, chloride, magnesium, and calcium.
Furosemide is already commonly used in children. Studies have compared the use of the drug alone vs its use with albumin to treat nephrotic edema in adults and children, but findings remain inconclusive. The EMA said that studies demonstrate the satisfactory quality of Bopediat and its bioequivalence to Lasilix Faible 20-mg tablets.
Bopediat is considered a hybrid medicine by the EMA because it contains the same active substance as Lasilix Faible but differs in strength and pharmaceutical form. Hybrid applications rely on results from both preclinical tests and clinical trials for a reference product as well as new data.
Detailed recommendations for using Bopediat will be published in the summary of product characteristics, which will be available on the EMA website in all official European Union languages should the European Commission grant the drug marketing authorization.
Annie Lennon is a medical journalist. Her writing appears on Medscape, WebMD, and Medical News Today, among other outlets.
