BioCentury
ARTICLE | Regulation

Handle with care

September 21, 2009 7:00 AM UTC

Following last week's unanimous FDA panel vote favoring approval of Xiaflex collagenase to treat Dupuytren's contracture, the agency now must decide whether Auxilium Pharmaceuticals Inc.'s proposed training system is sufficient for rheumatologists to safely inject Xiaflex. The Arthritis Advisory Committee was split on the issue of the degree of specialization needed for clinicians to safely administer the product.

Dupuytren's disease is a progressive condition characterized by the formation of thick, fibrous cords in the hand that eventually causes a forced flexion of one or more fingers inwards towards the palm. Patients with advanced disease are unable to straighten their fingers and as a result have trouble with everyday activities...