FDA Approves Astellas’ Anti-Fungal Drug

March 9, 2015
Pharmaceutical Technology Editors

Astellas Pharma announced that it received FDA approval for its treatment of fatal invasive fungal infections in patients with blood cancers.

 

On Mar. 6, 2015, Astellas Pharma announced that it received FDA approval for Cresemba (isavuconazonium sulfate), a treatment designated for two rare, invasive fungal infections that are often fatal. The indications are specifically for invasive aspergillosis, a life-threatening fungal infection found most often in immunocompromised patients, such as those with leukemia, and invasive mucormycosis, a rapidly progressing fungal infection.

Astellas applied for a new drug application, in which FDA subsequently approved Cresemba for the use in patients 18 years and older in immunocompromised patients with either invasive aspergillosis or invasive mucormycosis. The safety and efficacy was demonstrated through two Phase III clinical trials. Upon this approval, Astellas will be a milestone payment of CHF 30 million ($30.5 million USD) to Basilea Pharmaceutica International under a license and co-development agreement.

Source: Astellas