FDA has assigned a standard 10 month review to the iclaprim new drug application (NDA) and has established the Prescription Drug User Fee Act (PDUFA) action date for the NDA to be January 16, 2009.
The iclaprim NDA contains data from 15 clinical studies, including two well-controlled multinational pivotal Phase III trials (Assist-1 and Assist-2, in which approximately 1,000 patients were enrolled and treated). In these studies, iclaprim showed high clinical and microbiological cure rates and was well-tolerated with a safety profile which was compatible with treatment of patients with complicated skin and skin structure infections.
Jurgen Raths, CEO of Arpida, said: “We look forward to continue to work with the US authorities to facilitate their review of the NDA. In the meantime, work on the European filing is progressing and we expect to submit the marketing authorization application in the EU around the middle of 2008.”