– THERAKOS, the world's only fully integrated
and validated Extracorporeal Photopheresis (ECP)
system,1 received this CE certificate under the
EU's new and more rigorous certification process –
DUBLIN, Sept. 3, 2024 /PRNewswire/ -- Mallinckrodt plc, a global specialty pharmaceutical
company, announced that the THERAKOS™ CELLEX™ Photopheresis System
has obtained CE Certification under the updated European Union
Medical Device Regulation (EU MDR) 2017/745.
The EU MDR 2017/745 is a rigorous regulatory certification
program for medical devices intended to support innovation while
maintaining safety. The process for THERAKOS to achieve this new CE
certificate involved a quality management system audit of the
Dublin site, a technical review, a
microbiological review, and a thorough clinical assessment.
The EU MDR application for THERAKOS was submitted in
September 2022. Along with addressing
the new requirements for medical devices, this submission also
included two important design enhancements:
- The addition of the anticoagulant ACD-A to the current
labelling and relative Software changes to ensure optimal patient
and operator experience
- Material changes to remove DEHP (phthalate) and ensure
compliance to latest Restriction of Hazardous Substances in
Electrical and Electronic Equipment (RoHS) standards
THERAKOS is approved for use in patients who require the
administration of photopheresis. This includes patients older than
18 with Cutaneous T Cell Lymphoma or Solid Organ Transplant
Rejection (heart, lung), and patients older than 3 with Acute and
Chronic Graft versus Host Disease.
"We are pleased THERAKOS has received the CE Certificate under
the new EU MDR requirements that have been put in place to ensure
the highest quality and safety standards for medical devices in the
EU," said Christopher Hirt, MD,
Vice President Hospital International. "Importantly, THERAKOS
was granted this certificate after meeting the increased safety and
performance requirements, which may give healthcare providers even
greater confidence when treating patients."
About THERAKOS™ CELLEX™ Photopheresis System
The
THERAKOS CELLEX Photopheresis System is the world's only fully
integrated and validated ECP system.1 THERAKOS performs
ECP using patented technology that collects, separates and treats a
small amount of white blood cells (immune cells) while the patient
is connected to the instrument. The treated cells are then returned
to the patient where they help to modify the immune response in a
process called immunomodulation. It is used to treat a range of
immune-mediated diseases. THERAKOS Systems are used by over 300
treatment centres in over 30 countries worldwide.2
About Extracorporeal Photopheresis
(ECP)
Extracorporeal photopheresis (ECP) is an
immunomodulatory therapy that has demonstrated efficacy in various
T-cell and immune-mediated diseases.3 ECP is recommended
by international and national guidelines for a spectrum of
diseases, including cutaneous T-cell lymphoma (CTCL), acute and
chronic graft-versus-host disease (aGvHD and cGvHD), chronic lung
allograft dysfunction-bronchiolitis obliterans syndrome (CLAD-BOS)
and after cardiac
transplantation.4,5,6,7,8,9,10,11,12,13,14,15
IMPORTANT SAFETY INFORMATION FOR THE THERAKOS™ PHOTOPHERESIS
PROCEDURE UNDER EU MDR
Indications under EU MDR
The THERAKOS™ CELLEX™
Photopheresis System is indicated for patients older than 18 years
of age for the administration of photopheresis in the
following:
- Cutaneous T Cell Lymphoma (CTCL)
- Solid Organ Transplant Rejection (SOT) (heart, lung)
The THERAKOS™ CELLEX™ Photopheresis System is indicated in
patients older than 3 years of age for the management of:
- Acute and Chronic Graft versus Host Disease (aGvHD, cGvHD)
Contraindications
THERAKOS™ Photopheresis is contraindicated
in:
- Patients possessing a specific history of a light sensitive
disease
- Patients who cannot tolerate extracorporeal volume loss or who
have white blood cell counts greater than 25,000 /
mm3
- Patients who have coagulation disorders or who have previously
had a splenectomy
Warnings and Precautions
- THERAKOS™ Photopheresis treatments should always be
performed in locations where standard medical emergency equipment
is available. Volume replacement fluids and/or volume expanders
should be readily available throughout the procedure.
- Do not expose the device to a magnetic resonance (MR)
environment. The device may present a risk of projectile injury,
and thermal injury and burns may occur. The device may generate
artifacts in the MR image, or may not function properly.
- Thromboembolic events, including pulmonary embolism and deep
vein thrombosis, have been reported in the treatment of Graft
versus Host Disease (GvHD). Special attention to adequate
anticoagulation is advised when treating patients with GvHD.
- When prescribing and administering THERAKOS Photopheresis for
patients receiving concomitant therapy, exercise caution when
changing treatment schedules to avoid increased disease activity
that may be caused by abrupt withdrawal of previous therapy.
Adverse Events
- Hypotension may occur during any treatment involving
extracorporeal circulation. Closely monitor the patient during the
entire treatment for hypotension.
- Transient pyretic reactions, 37.7–38.9°C (100–102°F), have been
observed in some patients within six to eight hours of reinfusion
of the photoactivated leukocyte-enriched blood. A temporary
increase in erythroderma may accompany the pyretic reaction.
- Treatment frequency exceeding labelling recommendations may
result in anaemia.
- Venous access carries a small risk of infection and pain.
Please refer to the
THERAKOS™ CELLEX™ Photopheresis
System Operator Manual for a complete list of warnings and
precautions.
IMPORTANT SAFETY INFORMATION FOR METHOXSALEN USED IN
CONJUNCTION WITH THERAKOS™ PHOTOPHERESIS
Contraindications
Methoxsalen is contraindicated in:
- Patients exhibiting idiosyncratic or hypersensitivity reactions
to methoxsalen, psoralen compounds, or any of the excipients
- Patients with co-existing melanoma, basal cell or squamous cell
skin carcinoma
- Patients who are pregnant, and sexually active men and women of
childbearing potential unless adequate contraception is used during
treatment
- Patients with aphakia because of the significantly increased
risk of retinal damage due to the absence of a lens
Warnings and Precautions
- Special care should be exercised in treating patients who are
receiving concomitant therapy (either topically or systemically)
with known photosensitizing agents.
- Oral administration of methoxsalen followed by cutaneous UVA
exposure (PUVA therapy) is carcinogenic.
- Patients should be told emphatically to wear UVA absorbing,
wrap-around sunglasses for twenty-four (24) hours after methoxsalen
treatment. They should wear these glasses any time they are exposed
to direct or indirect sunlight, whether they are outdoors or
exposed through a window.
- Safety in children has not been established.
Refer to the package insert for methoxsalen sterile solution (20
micrograms / mL) or the oral 8-methoxypsoralen dosage formulation
for a list of all warnings and precautions.
Please refer to the
THERAKOS™ CELLEX™ Photopheresis
System Operator Manual for a complete list of warnings and
precautions and adverse events.
ABOUT MALLINCKRODT
Mallinckrodt is a global business consisting of
multiple wholly owned subsidiaries that develop, manufacture,
market and distribute specialty pharmaceutical products and
therapies. The company's Specialty Brands reportable segment's
areas of focus include autoimmune and rare diseases in specialty
areas like neurology, rheumatology, hepatology, nephrology,
pulmonology, ophthalmology, and oncology; immunotherapy and
neonatal respiratory critical care therapies; analgesics; and
gastrointestinal products. Its Specialty Generics reportable
segment includes specialty generic drugs and active pharmaceutical
ingredients. To learn more about Mallinckrodt, visit www.mallinckrodt.com.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING
STATEMENTS
This release contains forward-looking statements, including with
regard to THERAKOS, its potential to improve health and treatment
outcomes, and its potential impact on patients. The statements are
based on assumptions about many important factors, including the
following, which could cause actual results to differ materially
from those in the forward-looking statements: the effects of
Mallinckrodt's recent emergence from
bankruptcy; satisfaction of, and compliance with, regulatory and
other requirements; actions of regulatory bodies and other
governmental authorities; changes in laws and regulations; issues
with product quality, manufacturing or supply, or patient safety
issues or adverse side effects or adverse reactions associated with
THERAKOS; and other risks identified and described in more detail
in the "Risk Factors" and "Management's Discussion and Analysis of
Financial Condition and Results of Operations" sections of
Mallinckrodt's most recent Annual
Report on Form 10-K, Quarterly Reports on Form 10-Q, and other
filings with the SEC, all of which are available on its website.
The forward-looking statements made herein speak only as of the
date hereof and Mallinckrodt does not
assume any obligation to update or revise any forward-looking
statement, whether as a result of new information, future events
and developments or otherwise, except as required by law.
CONTACT
Media Inquiries
Green Room Communications
908-577-4531
mediainquiries@grcomms.com
Investor Relations
Derek Belz
Vice President, Investor Relations
314-654-3950
derek.belz@mnk.com
Mallinckrodt, the "M" brand mark,
and the Mallinckrodt Pharmaceuticals logo are trademarks
of a Mallinckrodt company. Other brands are trademarks of
a Mallinckrodt company or their respective owners.
©2024 Mallinckrodt. EU-2400172
09/24
References
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