EMEA's CHMP reiterates negative Mycograb opinion

The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has reiterated its negative approval opinion in relation to Switzerland-based drug major Novartis' developmental invasive candidiasis treatment Mycograb (efungumab). This follows the Swiss firm's request that the CHMP re-examine its decision (Marketletter November 27, 2006). Having done so, the Committee said that it has removed its concerns over the drug's association with cytokine release syndrome, suggesting it could be managed in clinical practice, but maintained its overall negative view of the agent on quality grounds, determining that its benefits did not outweigh its risks.