Vericel Announces FDA Approval of NexoBrid for the Treatment of Pediatric Patients with Severe Thermal Burns
15 Août 2024 - 10:05PM
Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies
for the sports medicine and severe burn care markets, today
announced that the U.S. Food and Drug Administration (FDA) has
approved a pediatric indication for NexoBrid® (anacaulase-bcdb) for
eschar removal in pediatric patients with deep partial-thickness
and/or full-thickness thermal burns.
“We are pleased that the FDA approved NexoBrid for pediatric use
as it provides a novel non-surgical solution for managing severe
burn injuries in this vulnerable pediatric patient population,”
said Nick Colangelo, President and CEO of Vericel. “We believe
NexoBrid is poised to become the new standard of care for eschar
removal and make a meaningful impact on the lives of adult and
pediatric burn patients, and we look forward to further executing
on our NexoBrid commercial launch.”
The FDA approval of the pediatric indication for NexoBrid is
based on the results of a global Phase 3 clinical trial, Children
Innovation Debridement Study (CIDS), which evaluated the safety and
efficacy of NexoBrid in hospitalized pediatric patients, as well as
additional pediatric data available from Phase 3 and Phase 2
studies conducted during the clinical development of NexoBrid.
Vericel is expanding its target customer base to include the
approximately 20 pediatric burn centers in the United States, which
the Company expects will have a meaningful impact on overall
NexoBrid uptake over time.
“For pediatric burn patients, NexoBrid represents a less
invasive alternative to traditional methods and the approval
ensures that children will now have access to this innovative
non-surgical option to quickly and effectively treat severe thermal
burns,” said Steven Kahn, MD, Chief of Burn Surgery at MUSC,
University Hospital and Shawn Jenkins Children’s Hospital.
NexoBrid was initially approved for eschar removal in adults
with deep partial-thickness and/or full-thickness thermal burns by
the FDA on December 28, 2022, and is commercially available in the
United States.
About NexoBridNexoBrid (anacaulase-bcdb) is a
biologic product containing proteolytic enzymes indicated for
eschar removal in adults and pediatric patients with deep partial-
and/or full-thickness thermal burns. To learn more about NexoBrid,
please visit www.NexoBrid-US.com.
Indications for Use: NexoBrid (anacaulase-bcdb)
is indicated for eschar removal in adults and pediatric patients
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
- 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 post-marketing 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.
- 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 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.
About Vericel Corporation
Vericel is a leading provider of advanced therapies for the
sports medicine and severe burn care markets. The Company combines
innovations in biology with medical technologies, resulting in a
highly differentiated portfolio of innovative cell therapies and
specialty biologics that repair injuries and restore lives. Vericel
markets three products in the United States. MACI® (autologous
cultured chondrocytes on porcine collagen membrane) is an
autologous cellularized scaffold product indicated for the repair
of symptomatic, single or multiple full-thickness cartilage defects
of the knee with or without bone involvement in adults. Epicel®
(cultured epidermal autografts) is a permanent skin replacement for
the treatment of patients with deep dermal or full thickness burns
greater than or equal to 30% of total body surface area. Vericel
also holds an exclusive license for North American rights to
NexoBrid® (anacaulase-bcdb), a biological orphan product containing
proteolytic enzymes, which is indicated for eschar removal in
adults and pediatric patients with deep partial-thickness and/or
full-thickness thermal burns. For more information, please visit
www.vcel.com.
Epicel and MACI are registered trademarks of Vericel
Corporation. NexoBrid is a registered trademark of MediWound Ltd.
and is used under license to Vericel Corporation. © 2024 Vericel
Corporation. All rights reserved.
Forward Looking Statements
This press release contains forward-looking statements.
Forward-looking statements are subject to risks and uncertainties
such as those described in Vericel’s periodic reports on file with
the Securities and Exchange Commission. Among the factors that
could cause actual results to differ materially from those set
forth in the forward-looking statements include, but are not
limited to, uncertainties associated with our expectations
regarding the market penetration for NexoBrid, physician and burn
center adoption of NexoBrid, and supply chain disruptions or other
events or factors affecting MediWound’s ability to manufacture and
supply sufficient quantities of NexoBrid to meet customer demand,
including but not limited to the ongoing Israel-Hamas war. Actual
results may differ materially from anticipated results.
Investor Contact:Eric Burnsir@vcel.com+1 (734)
418-4411
Media Contact:Julie Downsmedia@vcel.com
Vericel (NASDAQ:VCEL)
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