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FDA approves Astellas injectable antifungal drug for newborns

Published on 13/01/20 at 12:00pm

The FDA has approved the first antifungal drug to specifically treat invasive candidiasis in newborns.

From Astellas, the new drug for injection micafungin (Mycamine) was approved to treat multiple different conditions including: bloodstream infection, candidemia, acute disseminated candidiasis, candida peritonitis, abscesses without meningoencephalitis and/or ocular dissemination in infants younger than 4 months of age.

Laura Kovanda, Astellas Senior Director, said: “Although rare, invasive candidiasis in newborns constitutes a unique pathogenesis unlike that demonstrated in older children and adults as marked by a higher incidence of organ involvement, especially in the central nervous system.”

The clinical trial saw 168 patients, across nine clinical trials, testing various doses of the drug. However, the safety of the injection for treating candidemia and meningoencephalitis and/or ocular dissemination, has not been established and these may need further testing at a higher dose.

The micafungin injection was first approved to treat adults with esophageal candidiasis back in 2005, and in 2008 for adults with candidemia, acute disseminated candidiasis, Candida peritonitis, and abscesses. It was also approved in 2013 for treating paediatric indication in children older than 4 months.

Conor Kavanagh

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