risk for both Dupuytren’s and potential risk for Peyronie’s irrespective of Peyronie’s indications. disease in 2 circumstances: use indication. to treat a ventral deformity of the penis and use to treat an isolated hourglass deformity of However, taking into the penis. In both circumstances, account the risk use of Xiaflex could result in minimisation injury to the urethra because of measures in place the location of the plaque, and, for the Dupuytren’s thus, lead to permanent indication and damage. proposed for the Peyronie’s indication However, off-label use in the sponsor’s Dupuytren’s contracture was response to this not considered to be an recommendation is important potential risk in acceptable at this either Version 10 or Version 11 time. of the RMP. During the clinical program for Dupuytren’s contracture, the only restriction for the treatment of Dupuytren’s was in the thumb. This restriction was not for safety reasons but because of the difficulty in assessing efficacy in a joint that moves in multiple planes. The prescribing information in the United States and EU does not prohibit use in the thumb and thus, this is not an off-label use. A search was performed of the global safety database to determine if any off-label use has occurred with Xiaflex for Dupuytren’s contracture. No cases have been received representing off-label use for Dupuytren’s contracture. Based on this information, the MAH believes there is no basis to include off-label use as an important potential risk for the indication of Dupuytren’s contracture as no such circumstance has been identified or reported. EU RMP Version 11 is provided in updated Module 1.8.1. Pharmacovigilance Systems. According to milestones Study AUX-CC-806 has been This is acceptable. stated in the completed and a copy of the full pharmacovigilance plan, CSR is provided. Study AUX-CC-806 has been The efficacy results of this study completed. The sponsor demonstrate the therapeutic should provide an update to effectiveness of Xiaflex in the
risk for both Dupuytren’s and Peyronie’s indications. potential risk for Peyronie’s disease in 2 circumstances: use to treat a ventral deformity of the penis and use to treat an isolated hourglass deformity of the penis. In both circumstances, use of Xiaflex could result in injury to the urethra because of the location of the plaque, and, thus, lead to permanent damage. However, off-label use in Dupuytren’s contracture was not considered to be an important potential risk in either Version 10 or Version 11 of the RMP. During the clinical program for Dupuytren’s contracture, the only restriction for the treatment of Dupuytren’s was in the thumb. This restriction was not for safety reasons but because of the difficulty in assessing efficacy in a joint that moves in multiple planes. The prescribing information in the United States and EU does not prohibit use in the thumb and thus, this is not an off-label use. A search was performed of the global safety database to determine if any off-label use has occurred with Xiaflex for Dupuytren’s contracture. No cases have been received representing off-label use for Dupuytren’s contracture. Based on this information, the MAH believes there is no basis to include off-label use as an important potential risk for the indication of Dupuytren’s contracture as no such circumstance has been identified or reported. EU RMP Version 11 is provided in updated Module 1.8.1. Pharmacovigilance Systems. irrespective of indication. However, taking into account the risk minimisation measures in place for the Dupuytren’s indication and proposed for the Peyronie’s indication the sponsor’s response to this recommendation is acceptable at this time. According to milestones stated in the pharmacovigilance plan, Study AUX-CC-806 has been completed. The sponsor should provide an update to Study AUX-CC-806 has been completed and a copy of the full CSR is provided. The efficacy results of this study demonstrate the therapeutic effectiveness of Xiaflex in the This is acceptable.
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