The US Food and Drug Administration (FDA) has approved Astellas Pharma’s supplemental New Drug Application (sNDA) for Mycamine (micafungin for injection).
The antifungal drug is now approved to treat invasive candidiasis in paediatric patients less than four months of age.
The indication is for Candidemia, Acute Disseminated Candidiasis, Candida Peritonitis and Abscesses in patients without meningoencephalitis or ocular dissemination.
Astellas infectious diseases and oncology global development project leader Laura Kovanda said: “Although rare, invasive candidiasis in newborns constitutes 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.
“We’re pleased with this decision and the potential benefits Mycamine may offer to young infants and their families impacted by invasive candidiasis.”
Invasive candidiasis is a fungal infection caused by yeast. According to the Centers for Disease Control, every year, around 25,000 people are diagnosed with candidemia in the US.
FDA approval comes from safety trials of Mycamine on 168 paediatric patients less than 4 months old, with subjects administered with varying doses of Mycamine in nine clinical trials.
Approved dosage is 4 mg / kg once daily for the specific age group.
Astellas Pharma also signed an agreement last month to acquire genetic drugs developer Audentes Therapeutics for $3bn.
The acquisition will strengthen Astellas’ capabilities and resources in gene therapy.