TOKYO (dpa-AFX) - Monday, Astellas Pharma Inc. (ALPMY) announced that
Cresemba, also known as isavuconazonium sulfate, has been granted orphan drug
and pediatric exclusivity by the FDA.

This approval is for the treatment of invasive aspergillosis and invasive
mucormycosis in patients as young as one year old.

As Astellas now holds orphan drug exclusivity, it has been granted seven years
of exclusive marketing rights for Cresemba in these indications starting from
the approval date of the supplemental New Drug Application on December 8, 2023.
Additionally, pediatric exclusivity further extends this timeframe by an
additional six months.

The FDA had previously granted orphan drug exclusivity to Cresemba in 2015 for
the treatment of IA and IM in adults.



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