Arpida Ltd. (SWX: ARPN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for intravenous iclaprim in the treatment of complicated Skin and Skin Structure Infections (cSSSI). Arpida completed the submission of the NDA to the agency in March 2008. FDA has assigned a standard ten month review to the iclaprim NDA and has established the Prescription Drug User Fee Act (PDUFA) action date for the NDA to be 16 January 2009.
Dr Jürgen Raths, CEO of Arpida Ltd. commented: "We are very pleased with the FDA's acceptance of our NDA. This marks another step towards our goal of launching iclaprim and providing a promising treatment option for patients suffering from serious or life-threatening infections. 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 Authorisation Application in the EU around the middle of this year. Furthermore, we will increasingly focus on the build-up of a commercial structure."
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). Patients enrolled in both Phase III trials exhibited high incidences of methicillin-resistant Staphylococcus aureus (MRSA). 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 cSSSI.
Dr Jürgen Raths, CEO of Arpida Ltd. commented: "We are very pleased with the FDA's acceptance of our NDA. This marks another step towards our goal of launching iclaprim and providing a promising treatment option for patients suffering from serious or life-threatening infections. 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 Authorisation Application in the EU around the middle of this year. Furthermore, we will increasingly focus on the build-up of a commercial structure."
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). Patients enrolled in both Phase III trials exhibited high incidences of methicillin-resistant Staphylococcus aureus (MRSA). 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 cSSSI.
