Germany’s Bayer says that the European regulator has given the green light to the intravenous version of its Avelox (moxifloxacin) antibiotic in the treatment of complicated skim and skin structure infections.
The product is now approved in this new indication in all 17 European Union member states in which it is licensed, after winning the regulatory nod from the German Federal Institute for Drugs and Medical devices. Approval was based on clinical trial data, which showed that patients taking Avelox recorded an overall clinical success rate of more than 80%, as good as currently approved therapies for this indication.
The US Food and Drug Administration approved the product in this new indication last month, where it is marketed by Schering-Plough as part of an alliance signed last September [[13/09/04b]].
Each year, an estimated two million people suffer from complicated SSSI in France, Germany, Italy, Spain and the UK alone.