Astellas Receives FDA Approval to Expand MYCAMINE® Indication to Infants Under 4 Months for Invasive Candidiasis

Compiled by newborn

Astellas Announces FDA Approval of Supplemental New Drug Application for Mycamine (Micafungin Injection) for Infants Under 4 Months of Age, for the Treatment of Candidemia without Meningitis and/or Ocular Involvement, Acute Disseminated Candidiasis, Candidal Peritonitis, and Abscesses

In infants, neonatal candidiasis is associated with a 20% mortality rate, as well as significant morbidity and mortality. Mycamine was approved in 2005 for the treatment of Candida infections in adults; in 2013, it was approved for pediatric patients aged 4 months and older. With this approval, Mycamine became the first antifungal drug approved in the United States specifically for the treatment of invasive candidiasis in infants under 4 months of age.

Although rare, invasive candidiasis in neonates has a distinct pathogenesis different from that established in older children and adults, characterized by a higher incidence of organ involvement, particularly of the central nervous system. The safety of Mycamine in infants has been evaluated in nine clinical trials, involving a total of 164 infant patients under four months of age who received Mycamine at various doses. Regarding dosing, the approved dosage of Mycamine for neonates and infants under four months of age is 4 mg/kg once daily.

The active ingredient of Mycamine is micafungin, a novel echinocandin antifungal agent obtained through chemical synthesis and modification of natural products from the fungus Coleophoma empetri. It inhibits enzymes essential for fungal cell wall synthesis and exhibits fungicidal (lethal) activity against Candida species. This medication can be used concurrently with various other drugs, including the HIV protease inhibitor ritonavir and the immunosuppressants cyclosporine and tacrolimus.

Mycamine is indicated for pediatric and adult patients:

For the treatment of candidemia, acute disseminated candidiasis, Candida peritonitis, and abscesses in children aged 4 months and older and adults;

For use in children under 4 months of age, for the treatment of candidemia without meningitis and/or ocular dissemination, acute disseminated candidiasis, Candida peritonitis, and abscesses;

Indicated for the treatment of esophageal candidiasis in children aged 4 months and older, and in adults;

For the prevention of Candida infection in children aged 4 months and older and adults undergoing hematopoietic stem cell transplantation.

The most common adverse reactions to Mycamine in all adult and pediatric clinical trials include diarrhea, nausea, vomiting, abdominal pain, fever, thrombocytopenia, neutropenia, and headache. In pediatric patients under 4 months of age, the incidence of adverse reactions such as sepsis, acidosis, anemia, decreased oxygen saturation, and hypokalemia was ≥15%.

Mycamine is contraindicated in individuals with hypersensitivity to micafungin sodium, any component of Mycamine, or other echinocandins.

Reference Source: U.S. FDA Approves Supplemental New Drug Application (sNDA) for Expanded Indication of MYCAMINE® (micafungin for injection) for the Treatment of Invasive Candidiasis in Pediatric Patients Less Than 4 Months of Age