-
MabThera is the first biologic
treatment approved for moderate to severe cases of the rare
autoimmune disease pemphigus vulgaris (PV), and the first major
advancement in the treatment of the disease in more than 60
years
-
PV is a rare and potentially
life-threatening blistering condition which can cause severe pain
and disfigurement
-
MabThera is now approved in
Europe to treat four autoimmune diseases
Basel, 15 March 2019 - Roche (SIX: RO, ROG; OTCQX:
RHHBY) today announced that the European Commission has approved
MabThera® (rituximab) for the treatment of adults with moderate to
severe pemphigus vulgaris (PV), a rare condition characterised by
progressive painful blistering of the skin and/or mucous
membranes.[1] Extensive
blistering can lead to serious, life-threatening fluid loss,
infection and/or death.[2]
MabThera is the first biologic therapy approved by the European
Commission for PV and the first major advancement in the treatment
of the disease in more than 60 years. Following approval by the US
Food and Drug Administration (FDA) in June 2018 and today's
decision, MabThera is now approved to treat four autoimmune
diseases in the US and Europe.
"We're pleased to bring the first biologic medicine to the more
than 50,000 people in Europe suffering from pemphigus vulgaris,"
said Sandra Horning, MD, Roche's Chief Medical Officer and Head of
Global Product Development. "This MabThera approval provides a much
needed new treatment that has been shown to provide higher
remission rates than corticosteroids alone, which can cause
debilitating side effects."
The European approval is based on data from the phase III Ritux 3
trial, a Roche-supported randomised controlled study, conducted in
France, which evaluated MabThera plus a tapering regimen of oral
corticosteroids (CS) compared to a standard dose of CS alone, as a
first-line treatment in patients with newly diagnosed moderate to
severe pemphigus. The primary endpoint of the study was complete
remission at month 24 without the use of CS for two or more months.
The study demonstrated that 89.5% of people with PV treated with
MabThera, in combination with short-term oral CS treatment,
achieved complete remission without the use of CS for two or more
months, compared to 27.8% of people with PV receiving CS alone, the
current standard of care.[3] The results
of the Ritux 3 trial were published in The Lancet in March
2017.[4]
The Roche-sponsored phase III multicentre, randomised, double-blind
PEMPHIX study, evaluating the efficacy and safety of MabThera
compared with mycophenolate mofetil (MMF), an immunosuppressant, in
patients with moderate to severe PV, is ongoing.[5]
Recently, an international panel of experts, the International
Bullous Disease Group, published new recommendations on the
diagnosis and management of pemphigus in the Journal of the
American Academy of Dermatology, and recommended the use of an
anti-CD20 monoclonal antibody, such as MabThera combined with a
tapering regimen of oral CS, as a first-line therapy option for
moderate to severe pemphigus.[6]
About pemphigus vulgaris
Pemphigus vulgaris is an autoimmune, blistering disease, occurring
within the epidermis, affecting the skin and mucous
membranes.[1] It is the
most common type of a group of autoimmune disorders collectively
called pemphigus.[2] It is
estimated that around three in every 100,000 people are diagnosed
with this disease globally.[7]
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About the Ritux 3 trial
Ritux 3 is a Roche-supported phase III, prospective, multicentre,
parallel-group, open-label randomised trial (NCT00784589),
conducted in France by the French Study Group on Autoimmune Bullous
Diseases. It was designed to evaluate MabThera plus a tapering
regimen of oral corticosteroid (CS) treatment compared to a
standard dose of CS monotherapy as a first-line treatment in
patients with newly diagnosed moderate to severe
pemphigus.[4] The primary
endpoint of the study was complete remission at month 24 without
the use of corticosteroids for two or more months.
About the PEMPHIX study
A phase III, randomised, double-blind, double-dummy,
active-comparator, parallel-arm multicentre study (PEMPHIX,
NCT02383589), designed to evaluate the efficacy and safety of
MabThera compared with mycophenolate mofetil (MMF), an
immunosuppressant, in patients with moderate to severe active
pemphigus vulgaris requiring 60-120 mg/day oral prednisone (or
equivalent).[5]
About MabThera/Rituxan
MabThera (Rituxan in the US) in combination with methotrexate is
indicated for the treatment of adults with severe active rheumatoid
arthritis (RA) who have had an inadequate response or intolerance
to other disease-modifying anti-rheumatic drugs (DMARD) including
one or more tumour necrosis factor (TNF) inhibitor therapies.
MabThera/Rituxan, in combination with glucocorticoids, is indicated
for the treatment of adults with severe, active granulomatosis with
polyangiitis (Wegener's, GPA) and microscopic polyangiitis (MPA).
People with serious infections should not receive MabThera/Rituxan.
It is not known if MabThera/Rituxan is safe or effective in
children.
About Roche in rheumatology and
beyond
For more than 50 years, Roche has followed the science to pioneer
medicines for immune-mediated rheumatic diseases. First-in-class
anti-IL-6 receptor therapy Actemra/RoActemra (tocilizumab) has
treated more than one million people with debilitating conditions,
such as rheumatoid arthritis (RA), polyarticular and systemic
juvenile idiopathic arthritis, giant cell arteritis and chimeric
antigen receptor T-cell-induced cytokine release syndrome.
MabThera/Rituxan (rituximab), which targets CD20, has significant
clinical and real-world experience treating rheumatic conditions
including RA, granulomatosis with polyangiitis (GPA) and
microscopic polyangiitis (MPA). Roche aims to provide solutions for
people that need new treatments most, particularly those with
severe or life-threatening conditions and limited treatment
options. Our pipeline consists of treatments designed to target
immune pathways including a glycoengineered type II anti-CD20
antibody in lupus nephritis.
About Roche
Roche is a
global pioneer in pharmaceuticals and diagnostics focused on
advancing science to improve people's lives. The combined strengths
of pharmaceuticals and diagnostics under one roof have made Roche
the leader in personalised healthcare - a strategy that aims to fit
the right treatment to each patient in the best way
possible.
Roche is the world's largest biotech company, with truly
differentiated medicines in oncology, immunology, infectious
diseases, ophthalmology and diseases of the central nervous system.
Roche is also the world leader in in vitro diagnostics and
tissue-based cancer diagnostics, and a frontrunner in diabetes
management.
Founded in 1896, Roche continues to search for better ways to
prevent, diagnose and treat diseases and make a sustainable
contribution to society. The company also aims to
improve patient access to medical innovations by working with
all relevant stakeholders. Thirty medicines developed by Roche are
included in the World Health Organization Model Lists of Essential
Medicines, among them life-saving antibiotics, antimalarials and
cancer medicines. Moreover, for the tenth consecutive year, Roche
has been recognised as the most sustainable company in the
Pharmaceuticals Industry by the Dow Jones Sustainability Indices
(DJSI).
The Roche Group, headquartered in Basel, Switzerland, is active in
over 100 countries and in 2018 employed about 94,000 people
worldwide. In 2018, Roche invested CHF 11 billion in R&D and
posted sales of CHF 56.8 billion. Genentech, in the United
States, is a wholly owned member of the Roche Group. Roche is the
majority shareholder in Chugai Pharmaceutical, Japan. For more
information, please visit www.roche.com.
All trademarks used or mentioned in this release are protected by
law.
References
[1] Medscape.
Pemphigus Vulgaris. [Internet; cited March 2019]. Available
from:
http://emedicine.medscape.com/article/1064187-overview.
[2] International Pemphigus & Pemphigoid Foundation. Pemphigus.
[Internet; cited March 2019] Available from:
http://www.pemphigus.org/research/clinically-speaking/pemphigus/.
[3] European Medicines Agency. Summary of Product Characteristics
for MabThera. [Internet; cited March 2019]. Available from:
https://www.medicines.org.uk/emc/product/3801/smpc.
[4] Joly P, et al. First-Line Rituximab Combined with Short-Term
Prednisone Versus Prednisone Alone for the Treatment of Pemphigus
(Ritux 3): A Prospective, Multicentre, Parallel-Group, Open-Label
Randomised Trial. The Lancet. March 22, 2017.
[5] ClinicalTrials.gov. A Study to Evaluate the Efficacy and Safety
of Rituximab Versus Mycophenolate Mofetil (MMF) in Participants
With Pemphigus Vulgaris (PV). [Internet; cited March 2019].
Available from:
https://clinicaltrials.gov/ct2/show/NCT02383589.
[6] Murrell DF, et al. Diagnosis and Management of Pemphigus:
recommendations by an International Panel of Experts. Journal of
the American Academy of Dermatology. February 10, 2018.
[7] Skin Support, British Association of Dermatologists. Pemphigus
Vulgaris. [Internet; cited March 2019]. Available from:
http://skinsupport.org.uk/conditions-details/pemphigus-vulgaris.
Roche Group Media Relations
Phone: +41 61 688
8888 / e-mail: media.relations@roche.com
- Nicolas Dunant (Head)
- Patrick Barth
- Ulrike Engels-Lange
- Simone Oeschger
- Anja von Treskow
20190315_MR_EC approves Roche’s
MabThera for pemphigus vulgaris