NexoBrid® Clinical Efficacy

The safety and efficacy of NexoBrid were evaluated in two clinical studies.1

NexoBrid achieved a significantly higher incidence of ≥95% eschar removal vs gel vehicle1

≥95% Eschar Removal with NexoBrid vs Gel Vehicle

Study 1 eschar removal
  • 93% of subjects treated with NexoBrid achieved ≥95% eschar removal vs 4% with gel vehicle1

Median time to ≥95% eschar removal was significantly shorter with NexoBrid vs SOC1*

Median Time to ≥95% Eschar Removal

Median eschar removal time

NexoBrid resulted in a significantly lower incidence of excision for eschar removal vs SOC1*

Incidence of Excision for Eschar Removal

Excision removal bar chart
  • There was a 4% incidence of excision for eschar removal following treatment with NexoBrid vs 72% with SOC1

See Similar Endpoint Data from Study 2


NexoBrid achieved ≥95% wound closure in 31 days vs 36 days with SOC1*||¶

Median Time to ≥95% Wound Closure
(Safety Endpoint)

Better wound closure with NexoBrid

See Similar Endpoint Data from Study 2

*Standard of care (SOC) included a combination of surgical and non-surgical eschar removal procedures such as: tangential, minor, avulsion, Versajet, and/or dermabrasion excision per the investigators’ discretion.

The statistical test that resulted in this p-value was Fisher’s Exact Test.

The statistical test that resulted in this p-value was Wilcoxon-Gehan Test.

§The statistical test that resulted in this p-value was Wald Chi-Square.

||Study 1 used Kaplan-Meier methods to estimate median time to ≥95% wound closure for all target wounds (TWs) on a subject. This was a noninferiority endpoint.

Subjects were not evaluated frequently enough after achieving ≥95% wound closure to adequately assess time to 100% wound closure.

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Review Study 2:
NexoBrid compared to SOC1

Review the Data 

NexoBrid resulted in a significantly lower incidence of excision for eschar removal in deep partial thickness (DPT) wounds vs SOC1*

Incidence of Excision for Eschar Removal Performed on DPT Wounds

Eschar removal DPT
  • There was a 15% incidence of DPT wounds requiring excision for eschar removal following treatment with NexoBrid vs 63% with SOC1

See Similar Endpoint Data from Study 1


NexoBrid achieved ≥95% wound closure in 33 days vs 24 days with SOC2*§

Median Time to ≥95% Wound Closure (Per Subject)

NexoBrid closure rate

See Similar Endpoint Data from Study 1


NexoBrid was associated with a lower percentage of wounds autografted in DPT wounds vs SOC2*

DPT Wounds Requiring Autografts

Lower percentage of DTP wounds
  • NexoBrid resulted in a significant reduction of DPT wound autografts vs SOC (18% with NexoBrid vs 34% with SOC)2

NexoBrid was associated with a lower percentage of wound area autografted in DPT wounds vs SOC2*

DPT Wound Area Autografted

Lower percentage of wound area
  • The mean percent of DPT wound area autografted was significantly lower with NexoBrid vs SOC (8.4 ± 21.3 with NexoBrid vs 21.5 ± 34.8 with SOC)2

*Standard of care (SOC) included a combination of surgical and non-surgical eschar removal procedures such as: tangential, minor, avulsion, Versajet, and/or dermabrasion excision per the investigators’ discretion.

The statistical test that resulted in this p-value was Logistic Regression Model.

Study 2 used Kaplan-Meier methods to estimate median time to ≥95% wound closure in randomized subjects.

§Subjects were not evaluated frequently enough after achieving ≥95% wound closure to adequately assess time to 100% wound closure.

||The statistical test which resulted in this p-value was the log rank test.

The statistical test that resulted in this p-value was the Analysis of Covariance (ANCOVA) Model.

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Review Study 1:
NexoBrid Compared to SOC and gel vehicle

Review the Data 

Important Safety Information

Indication

NEXOBRID® (anacaulase-bcdb) is indicated for eschar removal in adults and pediatric patients with deep partial thickness (DPT) and/or full thickness (FT) thermal burns.

Limitations of Use

The safety and effectiveness of NEXOBRID have not been established for 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
  • Burns in patients with significant cardiopulmonary disease, including inhalation injury

NEXOBRID is not recommended for:

  • Wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance
  • Treatment of burn wounds where medical devices (e.g., implants, pacemakers, shunts) or vital structures (e.g., large vessels) could become exposed during eschar removal

Important Safety Information

Contraindications

NEXOBRID is contraindicated in patients with: known hypersensitivity to anacaulase-bcdb, bromelain, pineapples, or to any other components; known hypersensitivity to papayas or papain because of the risk of cross-sensitivity.

Important Safety Information

Indication

NEXOBRID® (anacaulase-bcdb) is indicated for eschar removal in adults and pediatric patients with deep partial thickness (DPT) and/or full thickness (FT) thermal burns.

Limitations of Use

The safety and effectiveness of NEXOBRID have not been established for 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
  • Burns in patients with significant cardiopulmonary disease, including inhalation injury

NEXOBRID is not recommended for:

  • Wounds contaminated with radioactive and other hazardous substances to avoid unforeseeable reactions with the product and an increased risk of spreading the noxious substance
  • Treatment of burn wounds where medical devices (e.g., implants, pacemakers, shunts) or vital structures (e.g., large vessels) could become exposed during eschar removal

Important Safety Information

Contraindications

NEXOBRID is contraindicated in patients with: known hypersensitivity to anacaulase-bcdb, bromelain, pineapples, or to any other components; known hypersensitivity to papayas or papain because of the risk of cross-sensitivity.

Warnings and Precautions

Hypersensitivity Reactions

Serious hypersensitivity reactions, including anaphylaxis, have been reported with postmarketing use of anacaulase-bcdb. If a hypersensitivity reaction occurs, remove NEXOBRID (if applicable) and initiate appropriate therapy.

Healthcare personnel should take appropriate precautions to avoid exposure when preparing and handling NEXOBRID (e.g., gloves, surgical masks, other protective coverings, as needed).

Coagulopathy

Avoid use of NEXOBRID in patients with uncontrolled disorders of coagulation. Use with caution in patients on anticoagulant therapy or other drugs affecting coagulation, and in patients with low platelet counts and increased risk of bleeding from other causes. Monitor patients for possible signs of coagulation abnormalities and signs of bleeding.

Adverse Reactions

The most common adverse reactions (>5%) in adults were pruritus, pyrexia, wound complication, anemia, vomiting and insomnia. The most common adverse reactions (>5%) in pediatric patients were pruritus, pyrexia and vomiting.

Use in Special Populations
Geriatric Use

Clinical studies of NEXOBRID did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.

To report negative side effects contact Vericel Corporation at 888-454-BURN (888-454-2876) or FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.

Please see Full Prescribing Information.

References: 1. NexoBrid Prescribing Information. Cambridge, MA. Vericel Corporation; 2023. 2. Data on File. BLA 761192; July 2022.