Announcement of listing on the NHI drug price standard and marketing of XIAFLEX® (collagenase clostridium histolyticum)
Asahi Kasei Pharma Corp.
Asahi Kasei Pharma is announcing that XIAFLEX injection (generic name: collagenase clostridium histolyticum) for the treatment of Dupuytren’s contracture has been listed on the National Health Insurance (NHI) drug price standard as of today. In addition, the launch of the product is scheduled on September 16, 2015.
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 obtained approval for the manufacture and marketing on July 3, 2015.
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
- Administration and dosage
- For adult patients, inject 0.58 mg of XIAFLEX into each palpable Dupuytren’s cord with a contracture of a metacarpophalangeal (MP) joint or a proximal interphalangeal (PIP) joint according to the injection procedure. When effect is not sufficient, injections may be administered up to 3 times per cord at approximately 4-week intervals.
- Manufactured and distributed by
- Asahi Kasei Pharma Corp.
- Date of approval for manufacturing and marketing
- July 3, 2015
- Date of NHI drug price listing
- August 31, 2015
- Date of initial marketing in Japan
- September 16, 2015 (scheduled)
- NHI drug price
- ¥193,861 per bottle with diluent, 0.58 mg
Precautions for proper use
To ensure proper use and safety, the approval of XIAFLEX is conditional upon administration by physicians who meet certain conditions.
- 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.