FDA sanctioned Auxilium Pharmaceuticals’ Xiaflex to treat Dupuytren contracture. The firm reports that the drug launch is planned for late March.
Pfizer, Auxilium's marketing partner for the therapy in Europe, states that the MAA for Xiaflex began earlier this month. The firm paid $75 million up front in December 2008 for rights to the drug in Dupuytren and Peyronie disease; Xiaflex is currently being evaluated in the latter indication at the Phase II stage.
Auxilium is also evaluating Xiaflex for frozen shoulder syndrome in a Phase II trial. The treatment is a biologic drug made from collagenase clostridium histolyticum. It works by breaking down the excessive buildup of collagen in the hand.
“Before the FDA approved Xiaflex, the only effective treatment for this hand disorder was surgery, which sometimes meant a long recovery and the need for physical therapy for patients,” points out Bob Rappaport, M.D., director, division of anesthesiology, analgesia, and rheumatology of the FDA’s Center for Drug Evaluation and Research. “Since there are no other nonsurgical alternatives for Dupuytren contracture, Xiaflex will be an important advance in the management of this disabling condition.”
Xiaflex is injected directly into the collagen cord of the hand. The most common adverse reactions in patients treated with Xiaflex were fluid buildup, swelling, bleeding, and pain in the injected area. Although no serious allergic reactions have been observed, such a response would not be unexpected because this foreign protein could prompt an immune system reaction.
FDA has required a risk evaluation and mitigation strategy program for Xiaflex, which consists of a communication plan and a medication guide. It 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 the drug.
Auxilium says that it will market the therapy to physicians who are experienced in injection procedures of the hand and treatment of Dupuytren contracture. Access to Xiaflex will be provided only after physicians have completed a training program, the company adds.
Auxilium’s sales and marketing team comprises approximately 100 field sales managers and representatives, reimbursement specialists, and managed market account directors. In addition, a staff of 11 trained medical science liaisons will provide support for Xiaflex.
In one 66-patient study, 44% of those injected with Xiaflex were treated successfully, compared to 5% for patients who received a placebo. In a separate 306-patient study, 64% of patients given Xiaflex were treated successfully, compared to 7% of patients receiving the placebo.