Approval for manufacture and sale of
XIAFLEX® (collagenase clostridium histolyticum) in Japan
Asahi Kasei Pharma Corp.
Asahi Kasei Pharma today obtained approval for the manufacture and sale of XIAFLEX* injection (generic name: collagenase clostridium histolyticum, development code: AK160) for the treatment of Dupuytren’s contracture in Japan.
XIAFLEX is a biologic owned by an affiliate of Endo International plc and it is sold in more than 20 countries around the world. Asahi Kasei Pharma received rights to develop and market XIAFLEX in Japan through an agreement concluded in March 2011. After conducting a Phase III clinical trial in Japan, Asahi Kasei Pharma filed an application for approval in July 2014.
Asahi Kasei Pharma looks forward to providing XIAFLEX as a nonsurgical treatment option for Dupuytren’s contracture in Japan.
- Product name
- XIAFLEX injection
- Generic name
- Collagenase clostridium histolyticum
- Dupuytren’s contracture
- XIAFLEX consists of a highly purified combination of several subtypes of collagenase derived from Clostridium histolyticum in specific proportion. As a locally injectable treatment, it is the first effective non-surgical therapy for adult Dupuytren’s contracture patients with a palpable cord, and is approved and sold in the US, the EU, Canada, and Australia for this indication.
Corporate profile of Endo International plc
- Dublin, Ireland
- About Endo
- Endo International plc is a global specialty pharmaceutical company focused on improving the lives of patients while creating value. Endo develops, manufactures, markets and distributes quality branded pharmaceutical and generic pharmaceutical products as well as over-the-counter medications through its operating companies.
About Dupuytren’s contracture
Dupuytren’s contracture is a condition that affects aponeurotic tissue (a kind of connective tissue) beneath the skin of the palm, causing a fixed flexion contracture of the fingers as the disease progresses. The incidence of Dupuytren’s contracture is highest in Caucasians of Northern European descent, but there remain many unknowns regarding its pathogenic mechanism. XIAFLEX is the only drug which shows effectiveness for the treatment of Dupuytren’s contracture, which has conventionally been treated by surgery.
About Clostridium histolyticum
Clostridium histolyticum is a gram-positive bacterium that secretes various kinds of collagenase-like proteinase which decompose tissue for it to feed on and multiply. As they exhibit strong enzymatic activity, the collagenases derived from Clostridium histolyticum are often used in the separation of cells from animal tissue during the course of various biochemical and physiological research.
Collagenases are enzymes which break apart collagen, a fibrous protein that plays a vital role in maintaining connective tissue and bones in animals.