Mallinckrodt Receives Approval in Japan of the CELLEX(R) Extracorporeal Photopheresis System for Treatment of Chronic Graft Versus Host Disease
PR87729
DUBLIN, Jan. 22, 2021 /PRNewswire=KYODO JBN/ --
Mallinckrodt plc (
), a global biopharmaceutical company, announced today that Japan's Ministry of
Health, Labour and Welfare (MHLW) approved the CELLEX(R) extracorporeal
photopheresis (ECP) system for the treatment of steroid-resistant or intolerant
chronic graft versus host disease (cGvHD) in adults.
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The approval was based on an open-label study conducted in patients with
steroid-resistant or intolerant cGvHD after allogeneic hematopoietic stem cell
transplantation at three institutions in Japan. The efficacy rate following
evaluation of response and changes in steroid dose 24-weeks after ECP
initiation was 66.7 percent (8/12 patients), the primary endpoint of the study.
Adverse events were observed in all patients (n=15, 106 events). Most of the
adverse events observed were considered as those of the primary disease or
associated with long-term treatment with steroids. There were no adverse events
unique to this treatment.
"We are very pleased that the CELLEX ECP System has been approved. As a
pharmaceutical company focused on improving outcomes for under-served patients
with severe and critical conditions, we strive to develop treatment options
that address unmet medical needs," said Masatoyo Gunji, the President of
Mallinckrodt Pharma K.K. "Treatment for patients with cGvHD who do not respond
to steroids has long been a challenge and is one of the more difficult aspects
in treatment of cGvHD. As a new treatment option, we expect the CELLEX ECP
System to play an important role in treatment of patients with cGvHD."
About Chronic Graft Versus Host Disease (cGvHD)
Graft versus host-disease is a common complication of hematopoietic stem cell
transplantation (HSCT) resulting in significant morbidity and mortality.(1) It
can be classified as acute or chronic based on the clinical presentation and
the time of occurrence after the transplantation. Signs and symptoms of cGvHD
nearly always occur within the first year post transplantation but can
occasionally happen several years later.(2) In cGvHD, the skin is the most
frequently affected organ with manifestations of itchy rash, hyper or
hypopigmentation and changes in texture. However, the disease can affect
multiple sites, which may have a major impact upon a patient's quality of
life.(2,3) Chronic GvHD can lead to debilitating consequences, such as joint
contractures, loss of sight, end-stage lung disease, or mortality resulting
from profound chronic immune suppression leading to recurrent or
life-threatening infections.(1)
IMPORTANT SAFETY INFORMATION
Intended Use or Efficacy
This system is used as extracorporeal photopheresis therapy in steroid
resistant or intolerant, chronic graft versus host disease.
Warnings
Directions for Use:
1. When conducting extracorporeal photopheresis therapy for patients receiving
other therapy, exercise caution when changing treatment schedules to avoid
increased disease activity that may be caused by abrupt withdrawal of previous
therapy.
2. Taking into account the condition of the patient, administer an appropriate
amount of anticoagulant through the CELLEX device, as thromboembolic events may
occur.
Contraindications / Prohibitions
Directions for Use:
1. Do not re-use (Procedural Kit and Methoxsalen Solution).
2. Do not operate the instrument in the presence of flammable anesthetic gases,
external radio or electromagnetic disturbances that may interfere with proper
performance of the device. There is the risk of ignition and malfunction.
Applicable subject (patient)
Do not use for the following population.
-- Patients who cannot tolerate extracorporeal volume loss as the patient
has possibility of hypotension and shock disease.
-- Patients exhibiting idiosyncratic reactions to psoralen compounds
including methoxsalen, or possessing a specific history of a light-
sensitive disease state.
-- Patients with aphakia because of the significantly increased risk of
retinal damage due to the absence of a lens.
-- Patients possessing a specific history of a disordered coagulation or
patients who have had previous splenectomy as anticoagulants is used
during therapy.
-- Patients during pregnancy and lactation as it is likely to cause harm
to the unborn child or suckling infant.
-- Patients who have white blood cell counts greater than 25,000/mm(3).
ABOUT THE THERAKOS CELLEX ECP SYSTEM
The CELLEX System delivers extracorporeal photopheresis (ECP), and consists of
an instrument, procedural kit, methoxsalen solution and a UVA lamp. ECP was
initially developed as a therapy for patients with Cutaneous T-Cell Lymphoma
(CTCL).
The CELLEX System was designated as a medical device to be introduced early in
Japan by the 15th Study Panel on Early Introduction of Highly Needed Medical
Devices. This meeting was organized by the MHLW and held on February 17, 2011.
CELLEX was also designated as an orphan medical device by the MHLW on January
18 2017.
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 and ophthalmology; 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.
Mallinckrodt uses its website as a channel of distribution of important company
information, such as press releases, investor presentations and other financial
information. It also uses its website to expedite public access to
time-critical information regarding the company in advance of or in lieu of
distributing a press release or a filing with the U.S. Securities and Exchange
Commission (SEC) disclosing the same information. Therefore, investors should
look to the Investor Relations page of the website for important and
time-critical information. Visitors to the website can also register to receive
automatic e-mail and other notifications alerting them when new information is
made available on the Investor Relations page of the website.
CAUTIONARY STATEMENTS RELATED TO FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements concerning the use of the
CELLEX System including potential benefits associated with its use. 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: satisfaction of 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; and other risks identified and described in
more detail in the "Risk Factors" section of Mallinckrodt's most recent Annual
Report on Form 10-K 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
Caren Begun
Green Room Communications
+1 201-396-8551
caren@greenroompr.com
Investor Relations
Daniel J. Speciale, CPA
Vice President, Finance and Investor Relations Officer
+1 314-654-3638
daniel.speciale@mnk.com
Mallinckrodt Pharma K.K.
Kazuo Nishiyama
Sales & Marketing, Product Manager
+81 3 6234 1650
kazuo.nishiyama@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. (c) 2021 Mallinckrodt. 1/21
REFERENCES
1 Filipovich, Biol Blood Marrow Transplant 2005; 11:945-956.
2 Jagasia 2015. Biol Blood Marrow Transplant. 2015; 21(3): 389-401.
3 Pavletic et al. Biol Blood Marrow Transplant. 2006;12:252-66.
SOURCE Mallinckrodt plc
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