Severe Burn Therapy NexoBrid Gets FDA Approval

The Food and Drug Administration (FDA) has approved NexoBrid^® (anacaulase-bcdb) for eschar removal in adults with deep partial thickness and/or full thickness thermal burns.

NexoBrid is a topically administered, bromelain-based biological product containing a sterile mixture of proteolytic enzymes. The product selectively removes burn eschar within 4 hours without harming surrounding viable tissue.

The approval of NexoBrid was based on data from 2 clinical trials. The phase 3 DETECT trial (ClinicalTrials.gov Identifier: NCT02148705) compared NexoBrid to gel vehicle placebo or standard of care (SOC) in 175 adults with deep partial and full thickness thermal burns up to 30% of total body surface area (BSA). Results showed the incidence of ≥95% eschar removal at the end of the topical treatment period for patients in the NexoBrid group was 93% vs 4% for the gel vehicle group (treatment difference, 89% [95% CI, 74-96]). NexoBrid was also associated with a lower incidence of surgical eschar removal (4% vs 72% for SOC). The median time to eschar removal was reported to be 1 day with NexoBrid and 3.8 days with SOC. The estimated median time to 95% or greater wound closure was 31 days for the NexoBrid arm and 36 days for the SOC arm.

NexoBrid was also evaluated in an open-label, 2-arm study (ClinicalTrials.gov Identifier: NCT00324311) that included patients with deep partial and full thickness thermal burns of 5 to 24% BSA (N=182). Of these patients, 156 were randomly assigned to receive NexoBrid or SOC; efficacy assessment was based on deep partial thickness burns only.  The incidence of surgical eschar removal for the NexoBrid group was 22% compared with 77% for the SOC group (treatment difference, -55% [95% CI, -71, -38]). The estimated median time to 95% or greater wound closure was 33 days for the NexoBrid arm and 24 days for the SOC arm.

The most common adverse reactions reported with NexoBrid were pruritus and pyrexia. The product is contraindicated for use in patients with known hypersensitivity to bromelain, pineapples, papayas or papain.

NexoBrid lyophilized powder and gel vehicle must be mixed prior to administration and should only be administered by a health care provider. Each vial of lyophilized powder, jar of gel vehicle, and the mixed NexoBrid are for use for 1 patient and for 1 application.

The product is expected to be available in the second quarter of 2023.

The safety and efficacy of NexoBrid have not been established for the treatment of: chemical or electrical burns; burns on the face, perineum, or genitalia; burns on the feet of patients with diabetes mellitus or on the feet of patients with occlusive vascular disease; circumferential burns; or burns in patients with significant cardiopulmonary disease, including inhalation injury. NexoBrid is not recommended for wounds contaminated with radioactive and other hazardous substances.

References

1. MediWound announces FDA approval of NexoBrid^® for the treatment of severe thermal burns in adults. News release. MediWound Ltd. December 29, 2022. Accessed January 3, 2023. https://www.globenewswire.com/news-release/2022/12/29/2580838/30505/en/MediWound-Announces-FDA-Approval-of-NexoBrid-for-the-Treatment-of-Severe-Thermal-Burns-in-Adults.html.
2. Vericel announces FDA approval of NexoBrid for the treatment of severe thermal burns in adults. News release. Vericel Corporation. December 29, 2022. Accessed January 3, 2023. https://www.globenewswire.com/news-release/2022/12/29/2580837/34447/en/Vericel-Announces-FDA-Approval-of-NexoBrid-for-the-Treatment-of-Severe-Thermal-Burns-in-Adults.html.
3. NexoBrid. Package insert. Vericel Corporation; 2022. Accessed January 3, 2023. https://nexobrid-us.com/pdf/nexobrid-full-prescribing-information.pdf.