FDA approves Xiaflex of BioSpecifics
The FDA has approved BioSpecifics Technologies' (BioSpecifics) Xiaflex, a new orphan-designated, bio
Auxilium has established a distribution network that will allow health care providers to access Xiaflex through specialty distributors, specialty pharmacies or in the institutional setting after they have undergone training on Xiaflex and its administration.
Auxilium plans to market Xiaflex to physicians who are experienced in injection procedures of the hand and treatment of Dupuytren's contracture and will only provide access to Xiaflex after physicians have attested to completion of a training program.
The FDA has required a risk evaluation and mitigation strategy (REMS) program for Xiaflex, which consists of a communication plan and a medication guide. This REMS program is designed to evaluate and mitigate known and potential risks and serious adverse events; to inform healthcare providers about how to properly inject Xiaflex and perform finger extension procedures; and, to inform patients about the serious risks associated with Xiaflex.
Pfizer, Auxilium's marketing partner for Xiaflex in Europe, has said that the scientific/technical review procedure for the Marketing Authorisation Approval (MAA) for Xiaflex in Europe began in January, 2010. Pfizer is responsible for marketing Xiaflex for Dupuytren's contracture and Peyronie's disease in 27 member countries of European Union and 19 other European and Eurasian countries.
Thomas Wegman, president of BioSpecifics, said: "We believe that patients afflicted with Dupuytren's contracture will greatly benefit from Xiaflex, the first pharmaceutical treatment for this disabling disease. We would like to acknowledge the efforts of the scientists and clinicians who have worked with Xiaflex over many years to usher in a new era of hope for millions of patients that suffer from this condition. We look forward to its commercial launch and to the results of clinical trials of Xiaflex in other indications."