Tuesday, 23 September 2014

US FDA Accepts New Drug Application Filing for Isavuconazole

Drug developer Astellas has applied for approval to bring its new antifungal medication to clinics in the United States (this antifungal drug approval application has already been accepted in Europe), A decision in the US is scheduled for March 8th 2015.


The US Food and Drug Administration (US FDA) has accepted for filing the New Drug Application (NDA) for Astellas' isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis), which are life-threatening fungal infections predominantly occurring in immuno compromised patients. In accordance with the FDA Prescription Drug User Fee Act (PDUFA), the FDA designated the date of March 8, 2015 for the completion of the review. 

The FDA designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for both invasive aspergillosis and invasive mucormycosis. QIDP status provides priority review and a five-year extension of market exclusivity in the United States. QIDP incentives were granted under the 2012 US Generating Antibiotic Incentives Now (GAIN) Act as a part of the FDA Safety and Innovation Act. Also, in 2013, isavuconazole was granted Orphan Drug status for invasive aspergillosis and invasive mucormycosis which, if approved, will result in the product having seven years of market exclusivity in addition to that provided under the GAIN Act.

Original article 

Interestingly as isavuconazole was initially developed by a different company: Basilea, the FDA's acceptance of filing for New Drug Application will trigger a multi-million dollar payment to Basilea, presumably because it represents an agreed point when the drug may start to make money for the development companies.

NB Basilea still owns the rights to market isavuconazole outside of the US! Global drug development and marketing sometimes gets very complicated!

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