Pharmaceutical giant Arpida have announced that the Anti-infective Drugs Advisory Committee of the US Food and Drug Administration (FDA) has voted 17 to two against the approval of intravenous iclaprim – an antibiotic currently in development for the treatment of patients with complicated skin and skin structure infections (cSSSIs) – including those caused by methicillin-resistant Staphylococcus aureus (MRSA).
Arpida remains confident in the efficacy and safety of intravenous iclaprim and its potential in combating serious resistant infections. Iclaprim has been tested against both vancomycin and linezolid, and in combined phase III studies that included nearly 1,000 patients with cSSSI, iclaprim has been shown to have high cure rates, exceeding 90% in the per-protocol population.
Iclaprim has demonstrated potent bactericidal (killing) activity against MRSA and an extended range of resistant pathogens, with a well tolerated side-effect profile. Arpida is fully committed to iclaprim’s development and will continue to work with the FDA to address any questions related to iclaprim in anticipation of the drug’s Prescription Drug User Fee Act (PDUFA) goal date of January 16, 2009.
In addition to the FDA regulatory application, the European Medicines Agency (EMEA) accepted intravenous iclaprim for review August 2008. In September 2008, Arpida filed a New Drug Submission for intravenous iclaprim in Canada.
Arpida continues to study the potential of iclaprim, including investigation of an oral formulation.
In early 2008, Arpida received FDA approval to conduct a phase II iclaprim “intravenous-to-oral” switch trial in patients with cSSSI. Patient enrolment was completed in September 2008 and results are expected in December 2008.
Additional studies are ongoing worldwide to investigate the use of intravenous iclaprim in hospital-acquired pneumonia, ventilator-associated pneumonia and healthcare-associated pneumonia.
Committed to the future development and commercialisation of iclaprim, Arpida has anticipated potential scenarios and instituted judicious business plans that allow for continued development of its portfolio of products. Arpida continues to work in close collaboration with regulatory authorities to obtain intravenous iclaprim market authorization in the United States and Europe.