July 30, 2008
Arpida Files MAA for Intravenous Iclaprim
Arpida has submitted a marketing authorization application for intravenous iclaprim for the treatment of complicated skin and soft tissue infections to the European Medicines Agency.
The iclaprim marketing authorization application (MAA) 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 treated), the company said. Patients enrolled in the Phase III trials exhibited a high incidence of methicillin-resistant Staphylococcus aureus (MRSA) as causative pathogen.
In both of these two independent Phase III trials, intravenous iclaprim achieved the pre-specified primary endpoint of non-inferiority as compared to linezolid, according to the company. In the studies, iclaprim was well-tolerated with a safety profile which compared favorably with the comparator in the treatment of patients with complicated skin and soft tissue infections (cSSTIs).
In addition to the cSSTI indication, intravenous iclaprim is also being developed for the treatment of patients with hospital-acquired pneumonia, ventilator-associated pneumonia or healthcare-associated pneumonia suspected or confirmed to be due to Gram-positive pathogens.