Xiaflex collagenase clostridium histolyticum regulatory update
The U.K.’s NICE issued a final appraisal determination (FAD) recommended against Xiapex collagenase clostridium histolyticum from Swedish Orphan to treat Dupuytren’s contracture in adult patients with a palpable cord only in the context of research. The committee said there were no trials that directly compared Xiapex with surgery and recommended that research be conducted to compare Xiapex with limited fasciectomy and percutaneous needle fasciotomy in patients with moderate Dupuytren’s contracture. NICE’s draft guidance issued in November recommended against the use of the injectable form of collagenase for the indication but the agency revised its decision following public consultation. The drug is also approved in the EU to treat Peyronie’s disease with a palpable plaque and curvature deformity of 30 degrees. ...