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First PIP recommendation to broaden Cancidas' EU indication

This article was originally published in Scrip

Executive Summary

Merck & Co's antifungal Cancidas (caspofungin) is set to have its approved indications expanded in the EU to include paediatric patients following a positive opinion from the EU's CHMP– the first to be made based on clinical trial data generated in accordance with an agreed paediatric investigation plan (PIP). The echinocandin is currently approved in Europe for the treatment of several severe fungal infections, and is now approved for use in these infections in children aged 12 months to 17 years. The indications are: treatment of invasive candidiasis; treatment of invasive aspergillosis in patients refractory to or intolerant of amphotericin B, lipid formulations of amphotericin B, and/or itraconazole; and empirical therapy for presumed fungal infections in febrile neutropenic patients. PIPs are agreed in advance by the European Medicines Agency Paediatric Committeeand are legally binding for companies developing medicinal products for use in the EU.

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