WAYNE, N.J., March 11 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals announced today that an orphan drug designation has been granted by the U.S. Food and Drug Administration (FDA) for ciprofloxacin dry powder inhaler (DPI) for management of pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients. A similar designation has already been granted by the European Medicines Agency. Ciprofloxacin DPI is an investigational drug-device combination that combines ciprofloxacin dry powder formulated using Novartis’ Proprietary PulmoSphere(R) technology with a delivery inhaler. Ciprofloxacin DPI is in Phase II development and is being studied for its safety and potential to improve lung function, as measured by the forced expiratory volume in 1 second (FEV1), in patients with CF.
Cystic fibrosis is a life-threatening inherited disease affecting the lungs, pancreas, liver, and intestines(1). Approximately 30,000 patients in the US are affected by CF(1). In 2008, the median age of survival for patients in the US was 37.4 years according to data compiled by the Cystic Fibrosis Foundation(2). The major consequences of the disease are pancreatic insufficiency and reduced lung function. Lung disease accounts for about 90 percent of the mortality associated with CF(3). Patients with cystic fibrosis have dehydrated, thickened respiratory secretions that are difficult to clear and provide an attractive environment for bacteria, thus increasing the risk of infection and inflammation(2).
Clinical Trials with Ciprofloxacin DPI
About Orphan Drug Designation in the United States
Under legislation passed by the U.S. Congress in 1983, the Orphan Drugs Act provides incentives to sponsors to develop products for rare diseases. The first sponsor who obtains marketing approval for a designated orphan drug or biological product is granted US market exclusivity for a seven-year period. Exclusivity begins on the date that the marketing application is approved by the FDA for the designated orphan drug and applies only to the indication for which the drug has been designated and approved. The approval of an orphan designation request does not alter the standard regulatory requirements and process for obtaining marketing approval. Safety and efficacy of a compound must be established through adequate and well-controlled studies.
Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup 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 Bayer’s public reports which are available on the Bayer website at www.bayer.com. The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.
References
Bayer HealthCare Pharmaceuticals
