Kaken Pharmaceutical: filed in Japan for regulatory approval of KMW-1

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Tokyo, June 28, 2021 – Kaken Pharmaceutical Co., Ltd. (“Kaken”, head office of Bunkyo-ku, Tokyo; chairman and deputy director Hiroyuki Horiuchi) announces that it has submitted a new drug application to the Japanese Ministry of Health and Labor and Welfare will seek approval for the manufacture and marketing of the drug. KMW-1 for the elimination of pressure ulcers.

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 rapid removal of dead or damaged tissue, called pressure sores, approximately four hours after application, without damaging surrounding healthy tissue.

In April 2016, Kaken entered into an exclusive licensing agreement with MediWound Ltd., based in Israel, and developed KMW-1, which is available in select countries under the NexoBrid brand.®. The phase 3 clinical trial in Japan, which included patients with deep partial and total burns, demonstrated a favorable efficacy and safety profile. If KMW-1 is approved, it will provide a new treatment option for burn patients by enabling non-invasive pressure ulcer removal.

About burning pressure ulcers and KMW-1

Dead or damaged tissue from burns is known as pressure sores, and their removal or “debridement” is a critical first step in the successful healing of severe burns. As part of current standard care, a burn ulcer is removed using non-selective surgery, which is traumatic and can lead to loss of blood and viable tissue.

KMW-1 selectively eliminates pressure sores within 4 hours of application without damaging surrounding healthy tissue. KMW-1 is expected to ease the burden on healthcare professionals and patients.

NexoBrid® has received marketing authorization in Europe, Israel, Argentina, South Korea, Russia and other countries.

KMW-1 was designated an orphan drug in Japan in February 2021.

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