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| |  FDA Approves Photofrin for Ablation of High-Grade Dysplasia in Barrett's Esophagus MONT SAINT-HILAIRE, QC -- August 4, 2003 -- Axcan Pharma Inc. ("Axcan" or the "Company") announced today that it has received approval from the United States Food and Drug Administration ("FDA") for the use of PHOTOFRIN photodynamic therapy ("PDT") in the ablation of High-Grade Dysplasia ("HGD") in Barrett's Esophagus patients who do not undergo esophagectomy. Photofrin PDT was also granted orphan drug designation for this indication, which guarantees a 7-year marketing exclusivity. "We are very pleased with this approval since the new indication of Photofrin PDT will allow us to fill an other therapeutic void in gastroenterology," commented Leon F. Gosselin, President and Chief Executive Officer of Axcan. "We expect to launch Photofrin PDT in the United States at the beginning of fiscal 2004 and to reach peak sales of U.S. $30-50 million within 5 to 7 years", he concluded. Photofrin PDT was recently approved in Canada for the ablation of HGD in Barrett's Esophagus patients and is still under review in Europe for a similar indication. Axcan also recently announced that it was supporting Phase II studies on the use of Photofrin PDT in the treatment of cholangiocarcinoma, an aggressive cancer that grows in the ducts that carry bile from the liver to the small intestine. ABOUT BARRETT'S ESOPHAGUS Barrett's Esophagus is a condition that results from prolonged heartburn in which the normal lining of the lower part of the esophagus is replaced, over time, by another type of lining normally present in the stomach. Barrett's Esophagus is clearly recognizable at endoscopy. Typically, Barrett's Esophagus develops during the process of healing after a chronic injury to the esophageal mucosa, such as the injury caused by the reflux of gastric juice in the esophagus. Continued reflux may cause dysplastic changes progressing from Low-Grade to High-Grade Dysplasia. Such dysplasia may lead to esophageal adenocarcinoma, a life-threatening condition. It is estimated, in North America, that 25,000 to 35,000 people suffer from High-Grade Dysplasia associated with Barrett's Esophagus, and approximately 5,000 to 7,000 new patients in North America are diagnosed with this condition each year. STUDY RESULTS The filing was based on a 208-patient multicenter, randomized, controlled, partially blinded, 2-arm trial, in which 138 patients were randomized to Photofrin PDT + omeprazole and 70 patients to omeprazole only, as a control group. Patients were followed every 3 months until four consecutive endoscopic results were negative for High-Grade Dysplasia and then semi-annually until the last enrolled patient had completed at least 24 months of follow-up evaluation after randomization. The length of follow-up ranged from 2 to 3.6 years. The primary efficacy endpoint, assessed after a minimum follow-up of 24 months, was the complete ablation of High-Grade Dysplasia. Photofrin PDT resulted in this response in 77% of treated patients, while omeprazole alone resulted in 39% (the difference between groups was significant, with p(less than)0.0001). Secondary efficacy endpoint analyses showed that 1) the median duration of the ablation of HGD was 987 days in the Photofrin PDT group and 98 days in the omeprazole-only group; 2) the proportion of patients who progressed to oesophageal cancer was about twice as high in the omeprazole-only group compared to PHOTOFRIN photodynamic therapy group (p(equal sign)0.006). Additional analyses showed that patients who failed to achieve a Complete Response in either group of patients had an approximately ten-fold higher risk of progression to cancer than patients who achieved a Complete Response.
SOURCE: Axcan Pharma Inc.
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