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Arpida Ltd. today announced that the European Medicines Agency (EMEA) has accepted for review its Marketing Authorisation Application (MAA) for intravenous iclaprim
Reinach, Switzerland | August 21, 2008 | Arpida Ltd. (SWX: ARPN) today announced that the European Medicines Agency (EMEA) has accepted for review its Marketing Authorisation Application (MAA) for intravenous iclaprim. Arpida is seeking approval of intravenous iclaprim in the European Union for the treatment of complicated Skin and Soft Tissue Infections (cSSTI). 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. In the studies, iclaprim was well-tolerated with a safety profile which compared favourably with the comparator in the treatment of patients with cSSTI.
Dr Paul Hadvary, Head of Development of Arpida Ltd., commented: “Iclaprim is under regulatory review at the major health authorities on both sides of the Atlantic. We are steadily continuing our progress towards our goal of launching intravenous iclaprim, thereby providing healthcare professionals with a new option in treating serious skin infections.”
In addition to the cSSTI indication, intravenous iclaprim is also being developed for the treatment of patients with hospital-acquired pneumonia (HAP), ventilator-associated pneumonia (VAP) or healthcare-associated pneumonia (HCAP) suspected or confirmed to be due to Gram-positive pathogens. This programme is currently in Phase II clinical evaluation. Moreover, an oral formulation of iclaprim is currently in a Phase II clinical trial in cSSSI as a potential step-down therapy following initial intravenous treatment.
SOURCE: Arpida |
