Date: 2014-04-14
Type of information: Initiation of preclinical development
phase:
Announcement: presentation of Xiapex® data at the 29th Annual European Association of urology congress
Company: Auxilium Therapeutics (USA) Swedish Orphan Biovitrum (Sobi) (Sweden)
Product: Xiapex® (EU)/ Xiaflex® (USA) (collagenase clostridium histolyticum)
Action
mechanism: Xiapex® (collagenase clostridium histolyticum), is a pharmacological treatment for Dupuytren\'s contracture and may be an alternative to invasive and often complicated surgery for patients. Xiapex® is a combination of two purified clostridial collagenases for injection that enzymatically disrupts the contracting cord and reduces the contraction. It is administered by local injection directly into the Dupuytren\'s cord - a procedure which can be carried out in an outpatient setting. Twenty-four hours after the injection, a finger extension procedure can be carried out as necessary to break the cord and allow extension of the finger. In addition, work is on-going to potentially file for approval of Xiapex® in the EU for the treatment of Peyronie\'s disease, the development of collagen plaque, or scar tissue, on the shaft of the penis.
Disease: Peyronie\'s disease
Therapeutic area:
Country:
Trial details:
Latest
news: * On April 14, 2014, Auxilium Pharmaceuticals and Swedish Orphan Biovitrum have announced that encore data were presented from multiple clinical trials evaluating the use of Xiapex/Xiaflex® (collagenase clostridium histolyticum or CCH) in adult patients with Peyronie\'s disease (PD). These data were presented at the 29th Annual European Association of Urology (EAU) Congress being held 11-15 April, 2014 in Stockholm, Sweden. Poster presentations on Xiapex/Xiaflex included analysis from the pivotal Phase 3 IMPRESS (The Investigation for Maximal Peyronie\'s Reduction Efficacy and Safety Studies) trials which evaluated Xiapex/Xiaflex for the treatment of PD. Xiaflex® is the first and only FDA-approved treatment proven effective for PD in men with a palpable plaque and a curvature deformity of 30 degrees or greater at the start of therapy. Highlights of the data related to the use of Xiapex/Xiaflex in PD include: A post-hoc analysis of the pooled data from the IMPRESS I and II Phase 3 trials showed improved clinical outcomes following CCH-treatment regardless of subjects\' baseline PD treatment history, erectile function scores, and/or prostatectomy history. The global safety analysis of seven clinical trials of CCH for the treatment of PD shows that the adverse events were mostly localized to the penis, non-serious and resolved without intervention before the next injection. Serious adverse events (SAEs) related to treatment were also all localised to the penis in these clinical studies. A total of 60 (5.7%) of CCH-treated subjects experienced at least one treatment-emergent SAE, 0.9% experienced treatment-related SAEs (five penile hematoma and four corporal rupture). These data were also presented at the American Urological Association (AUA) Meeting held 4-8 May, 2013 in San Diego. Work is on-going by Sobi to potentially file for approval of Xiapex® in the EU for the treatment of PD. Xiapex® is approved by the EMA for the treatment of Dupuytren's contracture, and as the Market Authorization Holder in Europe, Sobi intends to submit a Variation to the EMA to extend the Xiapex® label to include Peyronie\'s disease.
