Xydalba (dalbavancin) is EU approved for ABSSSI- Actavis + Angelini
Actavis plc announced that the European Commission has granted Actavis' subsidiary Durata Therapeutics International B.V., marketing authorization for Xydalba (dalbavancin) for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults. Xydalba is the first and only once-weekly IV antibiotic approved for the treatment of ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes.
Through a license and supply agreement with Angelini, an international group leader in the pharmaceutical and mass-market sectors, Xydalba will be commercialized in 36 countries, which include Italy ,Spain ,Poland, Portugal, many Eastern European countries, Russia,Turkey,and Commonwealth of Independent States.
Xydalba is marketed in the United States as Dalvance for injection. Dalvance is indicated for the treatment of adult patients with acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible Gram-positive bacteria, including MRSA.
Comment: Dalbavancin has comparable efficacy to vancomycin and a much lower dosing schedule compared to twice daily vancomycin. Competition will come from generic Zyvox (linezolid) as the Zyvox patent expires in March 2015 and Silvextro (tedizolid) from Bayer which is now CHMP recommended.
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