The FDA has approved collagenase clostridium histolyticum (CCH [XIAFLEX]) as the first medication to treat of Peyronie's disease (PD).
The FDA has approved collagenase clostridium histolyticum (CCH [XIAFLEX]) as the first medication to treat Peyronie's disease (PD).
CCH is an in-office biologic that has proven effective for PD in men with a palpable plaque and a curvature deformity of 30 degrees or greater at the start of therapy, according to the drug’s manufacturer, Auxilium Pharmaceuticals, Inc.
"In my practice, treating PD has been a challenge as, until now, we have had few options to offer our patients," said Martin K. Gelbard, MD, clinical trial investigator and urologist at UCLA School of Medicine, Los Angeles. "I believe the FDA approval of XIAFLEX is a significant achievement and offers a new option for urologists: the first approved in-office treatment to be administered non–surgically that is proven safe and effective for this physically and psychologically devastating disorder."
“[The] approval expands the available treatment options for men experiencing Peyronie’s disease, and enables them, in consultation with their doctor, to choose the most appropriate treatment option,” said Audrey Gassman, MD, of the FDA’s Center for Drug Evaluation and Research.
The FDA review and approval was based on the results of safety and efficacy data from the pivotal IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) trials, the phase III double-blinded, placebo-controlled studies that assessed CCH for the treatment of PD. In IMPRESS I and IMPRESS II at 52 weeks, both co-primary endpoints met statistical significance for mean percent change in penile curvature deformity and mean change in the PDQ bother domain score for treated subjects versus placebo patients.
The dose of CCH is 0.58 mg per injection administered into a Peyronie's plaque. Up to eight injections (four treatment cycles) may be administered in the course of treatment. Also, a penile modeling procedure is recommended after every treatment cycle of two injections in an effort to further disrupt the plaque. If more than one plaque is present, it should be injected into the plaque causing the curvature deformity.
Auxilium said it worked with the FDA to develop a risk evaluation and mitigation strategy (REMS) for CCH that went into effect after the product first received FDA approval in February 2010 for adults with Dupuytren's contracture with a palpable cord. Auxilium has further collaborated with the FDA to update the REMS with an Elements to Assure Safe Use (ETASU) for the drug's use in the treatment of PD in men with a palpable plaque and curvature deformity of ≥30 degrees at the start of therapy.
The goal is to certify that the appropriate physicians and practice sites are trained in the use of the agent and to attempt to mitigate the serious risk of penile fracture (corporal rupture) and other serious injuries to the penis such as hematoma.
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