German drug and chemicals group Bayer says that its antibiotic Avelox (moxifloxacin) has won approval in the USA, where it is marketed by Schering-Plough, for the treatment of complicated intra-abdominal infections. This new indication represents the sixth granted by the US Food and Drug Administration, and closely follows a green light for complicated skin and skin structure infections earlier this year.
Intra-abdominal infections are the result bacteria leaking from the gastrointestinal tract into the adjoining tissues, which can be triggered by disease, trauma or surgery in the abdomen. There are around 3.5 million cases each year in the USA, with a large number related to appendicitis.
Commenting on the drug’s capabilities, Dr Martin Springsklee, Head of Anti-Infective Global Clinical Development from Bayer HealthCare's Pharmaceuticals Division, said: “Avelox offers considerable benefits over standard therapy for intra-abdominal infections. Not only does it offer the convenience of a single daily-dose monotherapy but also allows an easy step-down from IV to oral treatment. This makes Avelox an attractive proposition for healthcare professionals treating this indication.”
News of the new indication will certainly be welcomed at Bayer, which is working hard to counter the effects of generic competition to its top antibiotic Cipro (ciprofloxacin). Expanding uses of Avelox, the healthcare unit’s eight-biggest seller with 2004 sales of 318 million euros, plays a key role in the group’s strategy to minimize the effect of generic erosion of sales and, consequently, Bayer says it is planning to make a submission to the European Regulatory authorities for this indication in due course.