Avelox® IV Approved in Europe to Treat Complicated Skin and Skin Structure Infections
Bayer HealthCare announced that Avelox® IV (moxifloxacin HCl, solution for Infusion) was approved for the treatment of complicated Skin and Skin Structure Infections (cSSSI). The approval procedure which was led by the German Regulatory Authority, (German Federal Institute for Drugs and Medical devices - BfArM), was successfully completed for this new indication in all 17 European Member States where Avelox IV is licensed.1 Last month, the United States Food and Drug Administration (FDA) approved the cSSSI indication for the USA where Schering-Plough Corporation has acquired the marketing rights for Avelox®.
(I-Newswire) - “The severity of cSSSI as a major cause of morbidity makes the approval of Avelox a significant achievement for the patient community,” said Dr Martin Springsklee, Head of Anti-Infective Global Clinical Development from Bayer HealthCare's Pharmaceuticals Division. “Treatment of these infections typically involves a combination of antibiotics, often requiring multiple doses per day. Since Avelox® features once-a-day monotherapy, it offers a convenient and effective treatment option for patients.”
The decision to grant this approval was based on international clinical data which demonstrated that patients taking Avelox® recorded an overall clinical success rate of more than 80 percent, as good as currently approved therapies for this indication.
A skin and skin structure infection is complicated when it meets any of the following criteria: 2
- takes place in the presence of a pre-existing wound or ulcer
- is caused by an underlying disease state that complicates response to treatment
- involves deeper soft tissue
- requires significant surgical intervention to resolve
Complicated SSSI is a painful and disruptive condition that not only places a significant burden on health care resources but is also responsible for employee absenteeism and lost work time. Each year, an estimated two million people suffer from the infection in France, Germany, Italy, Spain and the United Kingdom alone.
“This approval and our further plans with Avelox will establish this brand as a potent therapy for treatment beyond respiratory tract infections,” said Alan Westwood, Vice-President, Anti-infective Global Strategic Marketing from Bayer HealthCare's Pharmaceuticals Division.
About Avelox
Avelox® IV ( + oral sequential therapy ) is now approved to treat Community Acquired Pneumonia ( CAP ), and Complicated Skin and Skin Structure Infections ( cSSSI ).
Avelox® Oral is approved to treat Community Acquired Pneumonia ( CAP ) - except severe cases, Acute Bacterial Sinusitis ( ABS ) where adequately diagnosed, and Acute Exacerbations of Chronic Bronchitis ( AECB ).
In Germany Avelox is known as Avalox.
For Avelox prescribing information and indicated organisms, log on to www.avelox.com or email global.avelox@bayer.com.
About Bayer HealthCare AG
Bayer HealthCare AG, a subsidiary of Bayer AG, is one of the world's leading, innovative companies in the health care and medical products industry. In 2004, the Bayer HealthCare subgroup generated sales amounting to some 8.5 billion Euro. The company combines the global activities of the divisions Animal Health, Biological Products, Consumer Care, Diabetes Care, Diagnostics and Pharmaceuticals. Bayer HealthCare employed 35,300 people worldwide in 2004.
Bayer HealthCare's aim is to discover and manufacture innovative products that will improve human and animal health worldwide. The products enhance well-being and quality of life by diagnosing, preventing and treating disease.
Forward-Looking Statements
This news release contains forward-looking statements based on current assumptions and forecasts made by Bayer Group management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in our public reports filed with the Frankfurt Stock Exchange and with the U.S. Securities and Exchange Commission ( including our Form 20-F ). The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
1 Austria, Belgium, Denmark, Finland, Germany, Greece, Republic of Ireland, Luxembourg, Malta, The Netherlands, Sweden, Hungary, Estonia, Latvia, Lithuania, Slovakia and Slovenia.
2 U.S. Food and Drug Administration ( FDA ). Guidance for Industry: Uncomplicated and Complicated Skin and Skin Structure Infections - Developing Antimicrobial Drugs for Treatment. Available at http://www.fda.gov/cder/guidance/2566dft.pdf. Last accessed on June 10, 2005.
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