Xydalba (dalbavancin) is launched in the UK as a treatment of acute bacterial skin and skin structure infections.- Cardiome Pharma

Cardiome Pharma Corp. announced that it has launched Xydalba (dalbavancin) in the UK earlier than expected. The European Medicines Agency (EMA) approved Xydalba for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Xydalba ( Dalvance in the US) 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.

Comment: Cardiome Pharma Corp.has an exclusive license agreement with an affiliate of Allergan plc that will results in the Cardiome Group commercializing Xydalba (dalbavancin) in France , the U.K., Germany , Belgium , Nordic nations, certain other European nations (not already partnered), various Middle Eastern nations and Canada. Xydalba was approved by the European Medicines Agency (EMA) in February 2015 as a treatment for Acute Bacterial Skin and Skin Structure Infections (ABSSSIs) in adults and by the FDA in May 2014 for the treatment of adult patients with ABSSSI caused by susceptible Gram-positive bacteria, including MRSA. Dalbavancin is commercialized under the trade name Dalvance in the U.S. and Xydalba in certain countries outside the U.S.

Comment: Clinical trials showed dalbavancin to be at least as effective as vancomycin or linezolid at curing infection. According to Phase III data, between 87 percent and 94 percent of patients treated with Xydalba were cured, compared with between 91 percent and 93 percent of patients treated with any of the two comparators. Xydalba, however, provides a single dose option.