Merck & Co drug gets first nod under PIP
The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has made US drug major Merck & Co's Cancidas (caspofungin) its first recommendation based on a pediatric investigation plan (Marketletter February 12, 2007). The Merck drug for the treatment of severe fungal infections is now indicated to treat children as well as adults.
PIPs are drug development plans setting out measures to ensure that the necessary data are obtained through studies in children, when it is safe to do so, to support the authorization of pediatric medicines. PIPs must be agreed in advance by the EMEA's Pediatric Committee (PDCO).
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