MediWound Announces FDA Approval of NexoBrid® for the Treatment of Severe Thermal Burns in Adults
Potential to become the new standard of care for eschar removal in patients with deep partial- and/or full- thickness thermal burns
“We are pleased and excited that the FDA has approved NexoBrid, an innovative, non-surgical alternative for the treatment of severe burn injuries,” said
Past President of the
NexoBrid is already approved for use in 43 countries, including the
The BLA submission leading to FDA approval covered by a comprehensive battery of pre-clinical studies and 8 clinical studies, including the pivotal Phase 3 U.S. clinical study (DETECT), which evaluated the efficacy and safety of NexoBrid in adult patients with deep partial-thickness and full-thickness thermal burns of 3%-30% of total body surface area (TBSA).
The study met its primary endpoint of incidence of ≥95% eschar removal compared to gel vehicle, as well as all secondary endpoints, including shorter time to eschar removal, lower incidence of surgical eschar removal and lower blood loss compared to surgical and non-surgical standard of care (SOC), including both surgical and non-surgical eschar removal methods, with highly statistically significant results. A safety endpoint of non-inferiority in time to >95% wound closure compared with patients treated with SOC was also achieved. In addition, non-inferiority was established between NexoBrid and SOC in cosmesis and function of burn scars after 12- and 24-month follow-up. Overall, NexoBrid is safe and well tolerated.
NexoBrid can be applied in up to two applications of four hours each. A first application of NexoBrid may be applied to an area of up to 15% body surface area. A second application of NexoBrid may be applied 24 hours later, with a total treated area for both applications of up to 20% TBSA.
NexoBrid development has been supported in part with federal funding from
NexoBrid (anacaulase-bcdb) is a botanical drug product containing proteolytic enzymes indicated for the removal of eschar in adults with deep partial- and/or full-thickness thermal burns.
Indications for Use: NexoBrid (anacaulase-bcdb) is indicated for eschar removal in adults with deep partial-thickness and/or full-thickness 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.
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.
- Pain: Manage pain as appropriate for an extensive dressing change of burn wounds. At least 15 minutes prior to NexoBrid-related procedures ensure adequate pain control measures are in place.
- Proteolytic Injury to Non-Target Tissues: NexoBrid is not recommended for treatment of burn wounds where medical devices or vital structures could become exposed during eschar removal.
- 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 (>10%) were pruritus and pyrexia.
- Geriatric: 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 the FDA at 1-800-FDA-1088 (1-800-332-1088) or www.fda.gov/medwatch.
- For complete risk information, please see the Full Prescribing Information.
MediWound is a biopharmaceutical company that develops, manufactures, and commercializes novel, cost effective, bio-therapeutic solutions for tissue repair and regeneration. Our strategy is to leverage our enzymatic technology platform, focusing on next-generation therapies for burn care, wound care, and tissue repair.
NexoBrid® is our commercial orphan biological product for early non-surgical eschar removal of deep-partial and full-thickness thermal burns. It is a bromelain-based biological product containing a sterile mixture of proteolytic enzymes that selectively removes burn eschar within four hours without harming surrounding viable tissue. NexoBrid is currently marketed in the European Union,
EscharEx® is based on the same active pharmaceutical ingredient as NexoBrid. It is under development for the debridement of chronic and hard-to-heal wounds. Results from Phase 2 studies show that EscharEx is significantly more effective and faster than SOC or placebo control in debridement of VLUs and DFUs, with a good safety and tolerability profile.
MW005 is a topical biological drug under development for the treatment of low-risk Basal Cell Carcinoma (BCC). In a Phase I/II open-label, multicenter, randomized clinical trial conducted in the
Committed to innovation, we are dedicated to improving the standards of care and enhancing patient lives. For more information, please visit www.mediwound.com.
Cautionary Note Regarding Forward-Looking Statements
MediWound cautions you that all statements other than statements of historical fact included in this press release that address activities, events, or developments that we expect, believe, or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for the forward-looking statements contained herein, they are based on current expectations about future events affecting us and are subject to risks, assumptions, uncertainties, and factors, all of which are difficult to predict and many of which are beyond our control. Actual results may differ materially from those expressed or implied by the forward-looking statements in this press release. These statements are often, but are not always, made through the use of words or phrases such as “anticipates,” “intends,” “estimates,” “plans,” “expects,” “continues,” “believe,” “guidance,” “outlook,” “target,” “future,” “potential,” “goals” and similar words or phrases, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may,” or similar expressions.
Specifically, this press release contains forward-looking statements concerning the anticipated timing of commercial launch of NexoBrid, the benefits we expect to receive under our agreement with
These and other significant factors are discussed in greater detail in MediWound’s annual report on Form 20-F for the year ended December 31, 2021, filed with the Securities and Exchange Commission (“SEC”) on March 17, 2022, quarterly Reports of Foreign Private Issuer on Form 6-K and other filings with the SEC from time-to-time. These forward-looking statements reflect MediWound’s current views as of the date hereof and MediWound undertakes, and specifically disclaims, any obligation to update any of these forward-looking statements to reflect a change in their respective views or events or circumstances that occur after the date of this release except as required by law.
Chief Financial Officer
Source: MediWound Ltd.