Drugs Xagena
The European Union ( EU ) Commission has approved Xiapex ( Collagenase clostridium histolyticum ) for the treatment of adult men with Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
Peyronie's disease is a condition that involves the development of collagen plaque, or scar tissue, on the shaft of the penis.
Xiapex was approved in December 2013 by the Food and Drug Administration ( FDA ) in the United States for the treatment of Peyronie's disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.
Xiaflex ( Collagenase clostridium histolyticum ) is the trade name for Xiapex used in the United States.
Xiapex is also approved in the European Union for the treatment of Dupuytren's contracture in adult patients with a palpable cord.
The scar tissue, known as a Peyronie's plaque, may harden and reduce flexibility, which may cause bending or arching of the penis during erection.
Peyronie's disease can result in varying degrees of penile curvature deformity and disease bother ( encompassing concern about erection appearance, erection pain and the impact of Peyronie's disease on intercourse and on frequency of intercourse ).
Peyronie's disease is a disease with an initial inflammatory component. This inflammatory phase is poorly understood with a somewhat variable disease course and spontaneous resolution occurring in less than 13% of cases.
After approximately 12 months of disease, the disease is reported to often develop into a more chronic, stable phase.
The incidence of Peyronie's disease is estimated between 3 and 9%; however the disease is thought to be underdiagnosed and undertreated.
Xiapex is a combination of two purified clostridial collagenases for injection that enzymatically disrupts the contracting cord and collagen plaque and reduces the contraction.
Xiapex is administered by local injection directly into the Dupuytren's cord in the finger or in the plaque on penis.
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 Dupytren's affected finger.
As a complement to Xiapex injection treatment for Peyronie's disease, modelling of the penis is needed. Modelling is performed 24-72 hours after the second injection of the cycle in an attempt to further disrupt the plaque and help straighten the penis. ( Xagena )
Source: Swedish Orphan Biovitrum AB ( SOBI ), 2015
XagenaMedicine_2015
