FDA Committee Recommends Astellas DrugBy
Astellas reports that the US Food and Drug Administration’s (FDA) Anti-infective Drugs Advisory Committee has recommend approval of the company’s investigational once-daily intravenous and oral broad-spectrum antifungal drug, Cresemba (isavuconazonium) for the treatment of invasive aspergillosis, as well as for invasive mucormycosis, a fungal infections predominantly occurring in immune-compromised patients.
The Advisory Committee provides the FDA with independent expert advice and recommendations. The FDA is not bound by the committee’s guidance, but its input will be considered by the agency in its review of Cresemba’s new drug application (NDA), which was submitted by Astellas on July 8, 2014. According to the timelines established by the Prescription Drug User Fee Act (PDUFA), the review of the NDA is expected to be complete by March 8, 2015.
Cresemba is being co-developed with Basilea Pharmaceutica International Ltd. Basilea submitted a European marketing authorization application on July 16, 2014 for the treatment of invasive aspergillosis and mucormycosis in adults.