Cardiome Pharma Corp. announced that it received authorization from the French Transparency Pricing Commission to begin selling XYDALBA in France and that it has subsequently launched XYDALBA in France. The European Medicines Agency (EMA) approved XYDALBA in 2015 for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults and the single dose administration was approved in 2016. XYDALBA can be administered as either one 1500 mg dose or as a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered intravenously over 30 minutes.
Hugues Sachot, Cardiome’s Senior VP Commercial, commenting on the XYDALBA launch in France, said, “We are extremely pleased with the progress we’ve made to date in launching XYDALBA across our licensed territories in Germany, the UK and now France. We’ve expanded our resources and commercial infrastructure across our European direct sales markets in support of a successful launch and our efforts are paying off by launching on schedule and building excitement around this product within the infectious disease community. ”
“We are pleased that our medical professionals in France will now have access to XYDALBA,” said Dr. William Hunter, President and CEO. “We believe that XYDALBA’s efficacy as demonstrated in the DISCOVER trials and its flexible dosing options will resonate with our physicians by allowing them to choose how to manage therapy based on their patients’ needs and availability of resources.”
According to Datamonitor, the diagnosed incidence of ABSSSI was ~155,000 patients in 2012 and is expected to grow to over 176,000 by 2030. The ABSSSI hospital market in France is valued at ~$120M.