-Approval marks first combined indication label and first
regulatory approval in the world for UVADEX in conjunction with the
THERAKOS Extracorporeal Photopheresis (ECP) System for the
treatment of chronic GvHD in adults-
STAINES-UPON-THAMES, United
Kingdom, Oct. 31, 2019
/PRNewswire/ -- Mallinckrodt plc (NYSE:
MNK), a global biopharmaceutical company, today announced
that UVADEX® (methoxsalen) has received
regulatory approval in Australia
by the Therapeutic Goods Administration (TGA) for extracorporeal
administration with the
THERAKOS® CELLEX® Photopheresis
System. The treatment is indicated for steroid-refractory and
steroid-intolerant chronic graft versus host disease (cGvHD) in
adults following allogeneic hematopoietic stem cell (HSC)
transplantation. The TGA also approved Uvadex in conjunction with
the THERAKOS CELLEX Photopheresis System for the palliative
treatment of skin manifestations of cutaneous T-cell lymphoma
(CTCL) that is unresponsive to other forms of treatment.
The TGA approval marks the first combined indication label and
the first regulatory approval in the world for UVADEX in
conjunction with the THERAKOS Photopheresis System for the
treatment of chronic graft versus host disease in adults.
"The TGA approval of UVADEX with the Therakos ECP platform opens
up new treatment options for patients with these challenging
conditions," said Steven Romano,
M.D., Executive Vice President and Chief Scientific Officer,
Mallinckrodt. "The cGvHD indication
is also an important milestone for Mallinckrodt, confirming the potential benefit of
this therapeutic option for patients who are refractory to or
intolerant of steroid treatments."
About Chronic Graft Versus Host Disease
(cGvHD)
Graft-versus-host-disease is a common
complication of hematopoietic stem cell (HSC) transplantation
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
About Cutaneous T-Cell Lymphoma (CTCL)
Cutaneous
T-cell lymphoma (CTCL) is an umbrella term for a group of
non-Hodgkin lymphomas involving T lymphocytes that localize in the
skin. It is a relatively rare cancer, with 2,500 to 3,000 new cases
per year in the United
States.4 The age of onset of the condition is
typically greater than 50 years, with the incidence rising
significantly in the later decades of life.5 CTCL causes
visible skin symptoms ranging from a small rash to extensive
redness, peeling, burning, soreness, and itchiness all over the
body.6,7 CTCL falls into different
categories based on the severity of the disease and
symptoms.8
Minimum Product Information:
UVADEX® (methoxsalen) Concentrated Injection for
extracorporeal circulation via photopheresis (ECP)
This medicinal product is subject to additional monitoring in
Australia. This will allow quick
identification of new safety information. Healthcare professionals
are asked to report any suspected adverse events at
www.tga.gov.au/reporting-problems.
Indications in Australia: UVADEX (methoxsalen) is
indicated for extracorporeal administration with the THERAKOS
CELLEX Photopheresis System for the:
- treatment of steroid‑refractory and steroid‑intolerant chronic
graft versus host disease (cGVHD) in adults following allogeneic
HSC transplantation.
- palliative treatment of the skin manifestations of cutaneous
T-cell lymphoma (CTCL) that is unresponsive to other forms of
treatment.
Contraindications: History of idiosyncratic or
hypersensitivity reaction to methoxsalen, psoralen compounds or any
excipients of UVADEX; co‑existing melanoma, basal cell or squamous
cell skin carcinoma; lactation; aphakia. ECP procedure
contra-indications: Photosensitive disease; inability to tolerate
extracorporeal volume loss; WBC count > 25,000 mm3;
previous splenectomy; coagulation disorders. Special warnings
and precautions: Only physicians who have special
competence in the diagnosis and treatment of cGVHD and CTCL who
have special training and experience with the THERAKOS CELLEX
Photopheresis System should use UVADEX. Men and women being treated
with UVADEX should take adequate contraceptive precautions both
during and after completion of photopheresis treatment. Exposure to
large doses of UVA causes cataracts in animals, an effect enhanced
by the administration of oral methoxsalen. The patient's eyes
should be protected from UVA light by wearing wrap‑around,
UVA‑opaque sunglasses during the treatment cycle and during the
following 24 hours. Exposure to sunlight or ultraviolet
radiation (even through window glass) may result in serious burns
and, in the long‑term, "premature aging" of the skin therefore
patients should avoid exposure to sunlight during the 24 hours
following photopheresis treatment. Thromboembolic events, such as
pulmonary embolism and deep vein thrombosis, have been reported
with UVADEX administration through photopheresis systems for
treatment of patients with graft versus host disease. This product
contains 4.1% w/v ethanol and each 1 mL of UVADEX contains 40.55 mg
of ethanol. Caution is advised in patients with liver disease,
alcoholism, epilepsy, brain injury or disease. No specific
information is available for use in renal or hepatic impairment and
there is no evidence for dose adjustment in the elderly. The safety
and efficacy of UVADEX have not been established in children.
Use in pregnancy: Category D. Use in Lactation:
UVADEX is contra-indicated. Interactions with other
medicines: Effects on P450 system metabolism may affect
clearance / activation of other drugs (caffeine, paracetamol) or
may extend the methoxsalen half-life leading to prolonged
photosensitivity in patients. Methoxsalen binding to albumin may be
displaced by dicoumarol, warfarin, promethazine and tolbutamide
with potential for enhanced photosensitivity. Caution when treating
with concomitant photosensitising agents. Adverse effects:
In the clinical trials, published information and postmarketing
surveillance of UVADEX/ECP, adverse events were usually mild and
transient and in most cases, related to the underlying
pathology. Very common: diarrhoea, anaemia, nausea,
headache, hypertension, sinusitis, upper respiratory tract
infection, fatigue, pain in extremity, pyrexia, cough, dyspnoea,
cushingoid, dry eye, photophobia, toothache, anorexia.
Common: depression, lacrimation increased, abdominal pain,
hypokalaemia, paraesthesia oral, pharyngolaryngeal pain,
tachycardia, conjunctivitis, eye pain, visual acuity reduced,
dysphagia, chills, mucosal inflammation, nasopharyngitis,
contusion, blood pressure diastolic decreased, haemoglobin
decreased, hyperglycaemia, hypocalcaemia, neuropathy peripheral,
tremor, rash, hypotension. Additional adverse effects seen in
clinical trials include vomiting, infections. Adverse events
related to the ECP/CELLEX procedure – thromboembolism and severe
allergic reactions, vascular access complication, vasovagal spasm,
hickman catheter infection/thrombosis, headache,
hypercoagulability, haemolysis. Additional adverse events
identified post-marketing: anaphylactic reaction, allergic
reaction, dysgeusia, exacerbation of congestive heart failure,
sepsis, endocarditis, and vomiting. Dosage and
Administration: Chronic Graft versus Host Disease: Three
ECP treatments in the first week then two ECP treatments per
week for at least 12 weeks, or as clinically indicated. Cutaneous
T-cell Lymphoma: ECP treatment on two successive days each month
for six months. Patients who show an increase in skin scores after
eight treatment sessions may have their treatment schedule
increased to two successive days every two weeks for the next three
months. Refer to full Product Information and THERAKOS CELLEX
Operator's Manual for information regarding administration.
Store below 25°C. Date of first approval: 16 September 2019. Date of revision: 11 October 2019.
Indications and Prescribing Information for Uvadex vary
globally. Please refer to the individual country product label for
complete information.
Before prescribing Uvadex, please refer to the full Product
Information also available by calling + 1
800.778.7898.
ABOUT THERAKOS
Mallinckrodt is the world's only provider of
approved, fully-integrated systems for administering
immunomodulatory therapy through ECP. Its Therakos ECP platforms,
including the latest generation THERAKOS™
CELLEX™ Photopheresis System, are used by academic
medical centres, hospitals, and treatment centres in nearly 40
countries and have delivered more than 1 million treatments
globally. For more information, please
visit www.therakos.co.uk.
Terumo BCT is the exclusive distributor of the Therakos ECP
platform in Australia, as well as
Latin America and select countries
in Europe. To learn more about
Terumo BCT, visit www.terumobct.com.
UVADEX (methoxsalen) and THERAKOS CELLEX Photopheresis Systems
are separately approved in a number of global markets. Please refer
to your local approved labelling for Uvadex and the Operator's
Manual for CELLEX for more information on approved uses for
specific indications.
Before administering therapy using the THERAKOS CELLEX
Photopheresis System, please refer to the Operator's Manual
available at +61 2 9429 3600 or +1
(800)778-7898.
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, 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
for Mallinckrodt concerning THERAKOS
Photopheresis 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.
CONTACTS
Media Inquiries
James Tate
The Henley Group
+1 44 1491 570 971
james@henley.co.uk
Investor Relations
Daniel J. Speciale, CPA
Vice President, Investor Relations and IRO
314-654-3638
daniel.speciale@mnk.com
Mallinckrodt, the "M" brand mark and
the Mallinckrodt Pharmaceuticals logo are trademarks of
a Mallinckrodt company.
© 2019 Mallinckrodt. 10/19. FR-1900004
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