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news.Cardiome Pharma has launched XYDALBA for injection, a second-generation, semi-synthetic lipoglycopeptide, in the UK earlier than expected.
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The European Medicines Agency (EMA) approved XYDALBA for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.
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.
Commenting on the XYDALBA launch in the UK Cardiome's Senior VP Commercial Hugues Sachot said: "This is an exciting moment for Cardiome as we begin the commercial roll-out for XYDALBA across our European territories. XYDALBA is a key product for Cardiome and we've supported its launch by strengthening our regional European teams with the addition of strong medical and commercial teams who all have strong anti-infective expertise.
"The feedback we've received about XYDALBA from our physician advisory boards has been very positive and the flexible dosing options may hasten early discharge, thereby increasing bed availability. We are excited to have launched XYDALBA ahead of schedule."
Kiran Bhirangi, Cardiome's Head of Medical Affairs, said: "We are pleased that XYDALBA is now available to our medical professionals in the UK.
"The single dose option provides the opportunity that the patient will get a full course of antibiotic therapy without the need to return to the hospital multiple times for follow-up dosing. We believe that XYDALBA's efficacy as demonstrated in the DISCOVER trials1 and its flexible dosing options will resonate with our medical professionals 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 ~280,000 patients in 2012 and is expected to grow to over 400,000 by 2030.2 The UK ABSSSI hospital market is valued at ~$74M.
About XYDALBA
XYDALBA (dalbavancin) for injection is a second-generation, semi-synthetic lipoglycopeptide, which consists of a lipophilic side-chain added to an enhanced glycopeptide backbone. XYDALBA is the first and only 30-minute, one-dose treatment option for acute bacterial skin and skin structure infections (ABSSSI) that delivers a full course of IV therapy.
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 over 30 minutes.
XYDALBA demonstrates bactericidal activity in vitro against a range of Gram-positive bacteria, such as Staphylococcus aureus (including methicillin-resistant, also known as MRSA, strains) and Streptococcus pyogenes, as well as certain other streptococcal species.