Xiapex (collagenase clostridium histolyticum), a new non-surgical treatment option for Dupuytren’s contracture in adult patients with a palpable cord, has been granted marketing authorization by the European Commission and is expected to be available for use in some European markets later this year. Collagenase clostridium histolyticum is the first injectable treatment to be approved in the EU for the treatment of Dupuytren's contracture. Pfizer has the marketing rights to collagenase clostridium histolyticum in Europe, and Auxilium Pharmaceuticals, Inc. has the rights in the rest of the world.
Dupuytren’s disease is a slowly progressive connective tissue disorder that can cause the affected finger to bend into the palm of the hand. It affects approximately 13 percent of the European population. The disease starts in the palm of the hand with the appearance of a number of small lumps (called nodules), made of cells that can produce collagen.
As the disease progresses, excess collagen continues to build up and may eventually form into a rope-like cord under the skin. The cord extends from the palm into the finger and can gradually contract or bend the finger permanently toward the palm, known as Dupuytren’s contracture. Once contracture has occurred, the affected finger often impacts the ability to carry out everyday tasks.
“The availability of a treatment like Xiapex is an important step forward for patients with Dupuytren’s contracture,” said Geno Germano, president and general manager, Specialty Care and Oncology, Pfizer Inc. “The EU approval of this treatment for Dupuytren’s contracture is a testament to Pfizer’s commitment to bringing innovative medicines to patients.”
“We welcome today's decision by the European Commission to approve a new, non-surgical alternative for European physicians to treat their patients with Dupuytren’s contracture,” said Armando Anido, chief executive officer and president of Auxilium.
The EU approval of collagenase clostridium histolyticum is based on results from two pivotal studies, Collagenase Option for Reduction of Dupuytren’s (CORD I and CORD II). Data from CORD I showed that 64 per cent of cords that received injections of collagenase clostridium achieved a reduction in contracture of that joint to 5 degrees or less, approximately 30 days after the last injection, compared with 6.8 per cent of those injected with placebo (P <0.001). In CORD II, which had this same primary endpoint as CORD I, statistically significantly more cords injected with collagenase than placebo achieved a reduction in contracture of that joint to 5 degrees or less, approximately 30 days after the last injection (44.4 per cent vs 4.8 per cent; P <0.001).
“Dupuytren’s contracture can significantly impact a patient’s quality of life, as the affected finger often interferes with daily activities such as driving, washing one’s face or shaking hands. So a new alternative treatment for the condition is encouraging to those living with Dupuytren’s contracture across the EU,” said Dr Jörg Witthaut, consultant hand surgeon from Schön Klinik Vogtareuth Handchirurgie, Vogtareuth, Germany.
Pfizer is working closely with the in-country medicines regulatory bodies across the EU to launch the new treatment and anticipates that healthcare professionals will be able to prescribe the treatment in some European markets later this year.
Dupuytren’s disease is found more frequently in people of white northern European descent and the highest prevalence has been seen in northern Scotland, Iceland and Norway. The condition is more common in men who also tend to be more severely affected by Dupuytren’s disease than female patients.
Dupuytren’s disease can affect up to 20 per cent of men who are over 60 years of age, and 20 per cent of women who are over 80 years of age. This means that as the population ages, so does the incidence of Dupuytren’s disease.
Pfizer has the marketing rights to collagenase clostridium histolyticum in Europe, and Auxilium Pharmaceuticals, Inc. has the rights in the rest of the world. Collagenase clostridium histolyticum has been approved in the United States by the US Food and Drug Administration (tradename in the US: Xiaflex) for treatment of adult patients with Dupuytren’s contracture.
Collagenase clostridium histolyticum is a combination of two purified collagenases (collagenase is an enzyme capable of breaking down collagen), derived from the bacterium Clostridium histolyticum. It is the first pharmacological treatment to be developed for Dupuytren’s contracture and may be an alternative to invasive and often complicated surgery for patients in the EU.
Collagenase clostridium histolyticum is administered by local injection directly into the Dupuytren’s cord – a procedure which can be carried out in an outpatient setting. It works by breaking down the structure of the cord and, 24 hours after injection, a finger extension procedure can be carried out as necessary to break the cord and allow extension of the finger.
If contracture remains four weeks after treatment, another injection can be administered into the same cord, and the finger extension procedure can be carried out again. Injections and finger extension procedures may be administered up to three times per cord, at approximately four-week intervals.
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Auxilium Pharmaceuticals, Inc. is a specialty biopharmaceutical company with a focus on developing and marketing products to predominantly specialist audiences, such as urologists, endocrinologists, certain targeted primary care physicians, hand surgeons, subsets of orthopaedic, general, and plastic surgeons who focus on the hand, and rheumatologists.