Paladin Labs Inc. has announced that Health Canada approved Xiaflex (Collagenase Clostridium Histolyticum) for Peyronie’s disease.
The drug is also approved to treat patients Dupuytren’s contracture with a palpable cord – a hand deformity that leads to fingers becoming bent.
Peyronie’s disease is a condition in which collagen plaque, or scar tissue, accumulates on the shaft of the penis. The build-up may cause bending or arching of the penis during erection. It is not known how many men suffer from this condition, but it is estimated to affect 3 to 9% of the population.
Xiaflex contains 2 subtypes of collagenase that breaks up collagen build-up in Peyronie’s disease.
Health Canada approved the drug based on phase 3 clinical studies showing the drug to significantly improve penile curvature deformity in men with Peyronie’s disease.
The drug was approved in the United States for this condition in 2013.
In a news release, Livio Di Francesco, VP & General Manager of Paladin Labs said, “We are pleased to announce the commercial availability of Xiaflex in Canada for its new indication. As the only Health Canada-approved Peyronie’s disease treatment, Xiaflex is available to address a critical unmet need for men living with this distressing and sometimes painful condition.”