India, March 11 -- 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...