CHMP Grants Actavis' Subsidiary Durata Therapeutics International, a Positive Opinion for Xydalba for the Treatment of ABSSSI in Adults.

Actavis has announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has granted Actavis' subsidiary Durata Therapeutics International, a positive opinion for Xydalba (dalbavancin), for the treatment of acute bacterial skin and skin structure infections (ABSSSI) in adults.

Xydalba is a bactericidal lipoglycopeptide. Its mechanism of action in susceptible Gram-positive bacteria involves interruption of cell wall resulting in bacterial cell death.

Xydalba is active against important groups of Gram-positive bacteria, including strains of methicillin resistant Staphylococcus aureus (MRSA) and some S. aureus with reduced susceptibility to glycopeptides (GISA), as well as pathogenic streptococci.  In addition, it possesses a pharmacokinetic (PK) profile, which allows once-weekly intravenous (IV) dosing. The most common side effects are nausea, diarrhoea and headache.

"The CHMP positive opinion is a significant step forward to bringing Xydalba, a novel antibiotic treatment option, to patients," said David Nicholson, Actavis Senior Vice President, Global Brands R&D. "There is an unmet need that exists for patients suffering from serious skin infections caused by resistant organisms and we are committed to developing innovative antibiotic treatment options for patients worldwide."

The CHMP opinion will be sent to the European Commission for the adoption of a decision on an EU-wide marketing authorization.

Xydalba is marketed in the United States as Dalvance (dalbavancin) 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.