Arpida Submits Marketing Authorisation Application for Intravenous
(MAA) for intravenous iclaprim for the treatment of complicated Skin and Soft Tissue Infections (cSSTI) to the European Medicines Agency (EMEA). Iclaprim is a hospital antibiotic drug candidate with potent bactericidal (killing) activity against MRSA and an extended range of important pathogens.
The iclaprim 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 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.
Tags: skin cancer, skin care, skin cell, skin disease, skin health, skin problem, skin product, Skin Treatment
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