Arpida’s Iclaprim MAA Accepted for Review By European Medicines Agency
Arpida has announced that the European Medicines Agency has accepted for review its marketing authorization application for intravenous iclaprim.
Arpida is seeking approval of intravenous iclaprim in the EU for the treatment of complicated skin and soft tissue infections (cSSTI). Iclaprim is a hospital antibiotic drug candidate with potent bactericidal activity against methicillin-resistant Staphylococcus aureus (MRSA) and an extended range of important pathogens.
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). Patients enrolled in the Phase III trials exhibited a high incidence of 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. In the studies, iclaprim was well-tolerated with a safety profile which compared favorably with the comparator in the treatment of patients with cSSTI.
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.