Arpida submits iclaprim NDA to FDA

Swiss biotechnology firm Arpida has submitted a New Drug Application in an electronic format for intravenous iclaprim for the treatment of complicated skin and skin structure infections to the US Food and Drug Administration. The firm has requested a priority designation for the synthetic diaminopyrimidine which exhibits a rapidly bactericidal action against an extended spectrum of pathogens, including multidrug-resistant bacteria.

The iclaprim NDA contains data from 15 clinical studies, including two adequate and 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 studies exhibited high incidences of methicillin-resistant Staphylococcus aureus. In both independent Phase III trials, intravenous iclaprim achieved the pre-specified primary endpoint. In the studies, iclaprim was well-tolerated with a safety profile which was compatible with treatment of patients with cSSSI.

Paul Hadvary, head of development at Arpida, said: "we are convinced that iclaprim - if approved - has the properties to become a successful drug in the hospital antibiotics market. In this market there is a clear need for novel therapies, as several of the currently-available drugs are faced with reduced efficacy, emerging resistance or worrying side effects."