Kaken Pharmaceutical Co. Ltd.
Kaken Pharmaceutical Co. Ltd.
06/28/2021 | Press release | Distributed by Public on 06/27/2021 22:38
Kaken Has Filed an Application in Japan for Regulatory Approval of KMW-1
Tokyo, June 28, 2021 - Kaken Pharmaceutical Co., Ltd. ('Kaken', head office Bunkyo-ku, Tokyo; President and Representative Director Hiroyuki Horiuchi) announces that it has submitted a new drug application to Japan's Ministry of Health, Labour and Welfare to seek manufacturing and marketing approval of KMW-1 for the removal of burn eschar.
KMW-1 is a topical agent composed of a concentrate of proteolytic enzymes extracted from the stem of the pineapple plant. KMW-1 provides selective and quick removal of dead or damaged tissues, known as eschar, in approximately four hours after application, without harming the surrounding healthy tissues.
In April 2016, Kaken entered into an exclusive licensing agreement with MediWound Ltd., based in Israel, and has developed KMW-1, which is available in certain countries under the brand name NexoBrid®. The Phase 3 clinical trial in Japan, which enrolled patients with deep partial and full-thickness burn, has demonstrated a favorable efficacy and safety profile. If KMW-1 is approved, it would provide a new treatment option for burn patients by enabling non-invasive removal of eschar.
About the removal of burn eschar and KMW-1
Dead or damaged tissues from burn are known as eschar, and its removal or 'debridement' is a critical first step in the successful healing of severe burns. Under the current standard care, burn eschar is removed by resorting to non-selective surgery, which is traumatic and may result in loss of blood and viable tissues.
KMW-1 selectively removes eschar within 4 hours after application without harming the surrounding healthy tissues. KMW-1 is expected to alleviate burden on medical professionals and patients.
NexoBrid® has received marketing authorization in Europe, Israel, Argentina, South Korea, Russia, and other countries.
KMW-1 was designated as an orphan drug in Japan in February 2021.