The Japanese Ministry of Health, Labor, and Welfare (MHLW) has granted marketing authorisation for MediWound’s NexoBrid to remove nonviable burn tissue, or eschar.
NexoBrid is indicated to remove eschar in paediatric and adult patients with deep-partial and full-thickness thermal burns without surgery.
Japan is claimed to be the world’s first country to approve NexoBrid for people of all ages.
It is also approved by the MHLW under the orphan drug designation as a priority review for unmet medical needs.
Bromelain-based biological product, NexoBrid comprise a sterile mixture of proteolytic enzymes that can remove nonviable burn tissue, or eschar, selectively in four hours without harming the surrounding viable tissue.
MediWound’s Japanese partner Kaken Pharmaceutical has the exclusive right to market and distribute NexoBrid in the country and expects to launch it in the next year summer.
Currently, Nexobrid is marketed in the European Union and in other international markets.
Kaken Pharmaceutical president and representative director Hiroyuki Horiuchi said: “We are very excited to partner with MediWound and bring NexoBrid to patients in Japan.
“Broad evidence-based clinical studies and firsthand experience of leading experts worldwide show that NexoBrid will play a major role in the future of burn care. We look forward to making it the standard of care in Japan.”
The company stated that Nexobrid is at registration-stage with the Food and Drug Administration (FDA).
The regulator has set 1 January next year as a Prescription Drug User Fee Act (PDUFA) target date.
MediWound CEO Ofer Gonen said: “We look forward to partnering with Kaken Pharmaceutical and are confident that their proven track record of achieving market penetration will maximise the medical and commercial potential of NexoBrid in Japan.
“This approval further supports our global commercialization strategy to expand the use of NexoBrid to international markets via collaborations with local partners and through additional marketing approvals.”