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New Drugs Online Report for collagenase clostridium histolyticum
Information
Generic Name:
collagenase clostridium histolyticum 
Trade Name: Xiapex (EU), Xiaflex 
Synonym: AA4500, clostridial collagenase, Xiapex  
Entry Type: Licence extension  
 
Developmental Status
UK: Pre-registration (Filed) 
EU: Pre-registration (Filed) 
US: Launched 
UK launch Plans: Available only to registered users
Actual UK launch date:  
Comments
June 14: Sobi has filed for an extension of the label for Xiapex® (collagenase clostridium histolyticum) with the European Medicines Agency (EMA) to include the indication of Peyronie´s disease. [14] 
26/06/2014 10:38:36
Apr 14: Sobi intends to submit a Variation to the EMA to extend the Xiapex label to include Peyronie´s disease [13]  
15/04/2014 15:59:30
Dec 13: Approved in the US for the treatment of Peyronie´s disease [12] 
09/12/2013 08:58:59
Aug 13: US decision on approval has been put back from Sep to Dec 2013 [11]. 
28/08/2013 22:20:04
Nov 12: Pfizer announces it plans to terminate its agreement with Auxilium; from 24/4/13 commercial & marketing rights will revert to Auxilium [9]. 
06/12/2012 11:44:48
Nov 12: Filed in the US [8] 
08/11/2012 09:43:35
Jun 12: Plan to file in US by end 2012 [6]. 
06/06/2012 11:39:32
Collagenase clostridium histolyticum has orphan drug status in the US for Peyronie´s disease [2]. 
16/11/2011 11:35:27
Oct 10: PIII study has enrolled first patient [1]. 
12/10/2010 17:30:03
 
Trial or other data
Feb 13: The Journal of Urology has electronically published the uncorrected proof of the pivotal IMPRESS (The Investigation for Maximal Peyronie´s Reduction Efficacy and Safety Studies) [10] 
07/02/2013 16:52:15
Nov 12: Auxilium and Pfizer will end their European Union collaboration for Xiapex by Apr 13. The marketing rights and responsibility for Xiapex´s regulatory activities will revert to Auxilium [7]. 
08/11/2012 09:39:35
Jun 12: Results from two PIII studies IMPRESS I and II reported. Both trials were of similar design and each enrolled >400 subjects. In IMPRESS I at 52 weeks, Xiaflex met the co-primary endpoints vs placebo with a mean reduction in penile curvature deformity of 37.6% (vs 21.3%, p=0.0005) and a 3.3 point (44%) improvement in the Peyronie´s Disease Questionnaire (PDQ) bother domain [vs 2 points (27%) with placebo, p=0.0451]. In IMPRESS II at 52 weeks, the equivalent results were 30.5% vs 15.2% mean improvement in penile curvature deformity (p=0.0059) and a 2.4 point (32.4%) vs a 1.6 (20.7%) improvement in the PDQ bother domain (p=0.0496). The most common AEs were local to the treatment site and included injection site hematoma, pain and swelling. There were 3 serious AEs of corporal rupture (penile fracture) and 3 of serious haematomas related to XIAFLEX reported [6]. 
06/06/2012 13:26:09
NCT01221623, NCT01221597 & NCT01243411 are all expected to complete Mar 12 [4]. 
25/04/2012 14:16:58
Dec 11: Recruitment complete in the open-label study in the US, EU and New Zealand (ref number NCT01243411) [3]. 
25/04/2012 14:14:39
Mar 11: Recruitment complete in two double-blind studies in the US & Australia (ref numbers NCT01221623, NCT01221597) in Mar 11 [3]. 
25/04/2012 14:14:10
Oct 10: The PIII development plan, IMPRESS (The Investigation for Maximal Peyronie´s Reduction Efficacy and Safety Studies), consists of four studies: two double-blind studies, with at least 600 patients from the US and Australia randomised 2:1 to XIAFLEX and placebo; one one open label study with 250 patients from the US, EU and New Zealand; and one pharmacokinetic study in 16 patients. XIAFLEX will be administered twice a week every 6 weeks for up to 4 treatment cycles. Each treatment cycle will be followed by a penile modeling procedure. Patients will be followed for 52 weeks post-first injection in the double-blind studies and for 36 weeks in the open label trial. The trials´ co-primary endpoints are the change from baseline in the ‘bother’ domain of the Peyronie´s Disease Questionnaire (PDQ) and % improvement from baseline in penile curvature, vs placebo. The PDQ has been accepted for use in the programme by the FDA´s Study Endpoint and Label Development (SEALD) Division [1]. 
12/10/2010 17:31:11
   
References  
Available only to registered users
Category
BNF Category:
Musculoskeletal and joint diseases (10)
Pharmacology: Collagenase stimulant  
Epidemiology: Prevalence seems to be 3-9% with an average age of onset in the fifth life decade [5].  
Indication: Peyronie's disease  
 
Method(s) of Administration
Intralesional 
 
Company Information
Name: Swedish Orphan Biovitrum (Sobi) 
US Name: Auxilium Pharmaceuticals 
 
NICE Information
Anticipated Commissioning route (England)
In timetable: -  
   
   
PBR Specified high cost drug.
   
Implications Available only to registered users