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news.Irish pharmaceutical firm Actavis has received marketing approval from the European Commission for Xydalba (dalbavancin), a once-weekly IV antibiotic, to treat acute bacterial skin and skin structure infections (ABSSSI) in adults.
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Xydalba is approved to treat ABSSSI with a two-dose regimen of 1000 mg followed one week later by 500 mg, each administered over 30 minutes.
Actavis executive vice president Global Brands Research and Development David Nicholson said: "The unique dosage regimen of Xydalba provides a new treatment approach that gives patients, healthcare professionals and hospitals greater flexibility in managing serious skin infections in both inpatient and outpatient sites of care."
Under a license and supply deal, Xydalba will be commercialized by Angelini in 36 countries, including Italy, Spain, Poland, Portugal, many Eastern European countries, Russia, Turkey, and Commonwealth of Independent States.
Angelini Pharmaceutical Division chief executive officer Gianluigi Frozzi said: "The new approach will allow patients, healthcare professionals and hospitals to overcome the standard daily or twice-daily IV antibiotic infusions.
"The agreement is part of the Angelini effort in the field of treatment of infectious diseases. Now approved in the EU, our experienced sales force and extensive network will bring Xydalba to over 30 countries."
The approval follows a positive opinion from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) in December 2014 and is applicable to all 28 Member States and the three European Economic Area countries not Member States of the EU.
In the US, Xydalba is marketed as Dalvance (dalbavancin) for injection and is indicated to treat adult patients with ABSSSI caused by susceptible Gram-positive bacteria, including MRSA.