-
Hemlibra donation will provide
prophylactic treatment to as many as 1,000 people with haemophilia
A over five years in countries where there is little or no access
to haemophilia treatment
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Donation will substantially
increase the number of people receiving prophylactic treatment for
haemophilia A through the World Federation of Hemophilia
Humanitarian Aid Program
Basel, 6 February 2019 - Roche (SIX: RO, ROG;
OTCQX: RHHBY) today announced that it has joined the World
Federation of Hemophilia (WFH) Humanitarian Aid Program, a landmark
initiative leading the effort to change the lack of access to care
and treatment for people with inherited bleeding disorders in
developing countries. Together with Chugai and Genentech, members
of the Roche Group, Roche's commitment to the WFH Program consists
of a donation of Hemlibra® (emicizumab), a prophylactic treatment
for haemophilia A, and funding to deliver the WFH Program's
integrated care development training to ensure that local
infrastructure and medical expertise are available to optimise and
appropriately use the donated Hemlibra.
The donation will provide prophylactic treatment with Hemlibra to
as many as 1,000 people with haemophilia A in developing countries,
over the course of five years, with a focus on high-need patients,
such as people of all ages with factor VIII inhibitors and children
without factor VIII inhibitors. Access to prophylactic treatment -
the standard of care for haemophilia A to prevent bleeds in most of
the developed world - is particularly restricted in developing
countries, with limited resources reserved for emergency situations
and acute bleeds. [1, 2] The WFH Humanitarian Aid Program currently
provides prophylactic treatment to approximately 1,500 people with
haemophilia A.
"Thanks to Roche's donation, significantly more people with
haemophilia A will be able to receive prophylaxis through the WFH
Humanitarian Aid Program. Importantly, the donation will also
provide a treatment option for people with haemophilia A with
factor VIII inhibitors who previously had very limited or no
treatment," said Alain Weill, WFH President. "Increasing access to
prophylactic treatments can make a profound difference in countries
where haemophilia A remains underdiagnosed and
untreated."
Most people with haemophilia in developing countries receive no or
inadequate treatment, which significantly affects their health,
quality of life and life expectancy. Children with severe
haemophilia in countries where there is no access to treatment
often do not survive to adulthood. [3]
"We are proud to join the WFH Humanitarian Aid Program, a landmark
initiative leading the effort to change the lack of access to care
and treatment for people with inherited bleeding disorders in
developing countries," said Bill Anderson, CEO Roche
Pharmaceuticals. "Our partnership with the WFH reflects our
commitment to the haemophilia community and to supporting rapid,
broad and sustainable access to Hemlibra for all people with
haemophilia A around the world who may benefit from this important
treatment option."
Hemlibra is the only prophylactic medicine that can be given
subcutaneously and offers effective bleed control with dosing
options as infrequent as every four weeks. [4] Hemlibra has been
studied in one of the largest pivotal clinical trial programmes in
people with haemophilia A with and without factor VIII inhibitors,
including four phase III studies (HAVEN 1, HAVEN 2, HAVEN 3 and
HAVEN 4). Hemlibra has been approved for routine prophylaxis to
prevent or reduce the frequency of bleeding episodes in people with
haemophilia A with factor VIII inhibitors in over 50 countries
worldwide. On 4 October 2018, Hemlibra was approved by the US Food
and Drug Administration (FDA) for routine prophylaxis to prevent or
reduce the frequency of bleeding episodes in adults and children,
ages newborn and older, with haemophilia A without factor VIII
inhibitors.[3] On 1 February 2019, the EU Committee for Medicinal
Products for Human Use (CHMP) adopted a positive opinion for
Hemlibra (emicizumab) for routine prophylaxis of bleeding episodes
in adults and children with severe haemophilia A without factor
VIII inhibitors. Submissions to, and approvals by, other regulatory
authorities around the world are ongoing.
To learn more about the WFH and the Humanitarian Aid Program visit
https://www.wfh.org/en/humanitarian-aid-program.
About Hemlibra® (emicizumab)
Hemlibra is a bispecific factor IXa- and factor X-directed
antibody. It is designed to bring together factor IXa and factor X,
proteins required to activate the natural coagulation cascade and
restore the blood clotting process for people with haemophilia A.
Hemlibra is a prophylactic (preventative) treatment that can be
administered by an injection of a ready-to-use solution under the
skin (subcutaneously) once-weekly, every two weeks or every four
weeks. Hemlibra was created by Chugai Pharmaceutical Co., Ltd. and
is being co-developed globally by Chugai, Roche and Genentech. It
is marketed in the United States by Genentech as Hemlibra
(emicizumab-kxwh), with kxwh as the suffix designated in accordance
with Nonproprietary Naming of Biological Products Guidance for
Industry issued by the US Food and Drug Administration.
About Roche in haematology
For more than 20 years, Roche has been developing medicines that
redefine treatment in haematology. Today, we are investing more
than ever in our effort to bring innovative treatment options to
people with diseases of the blood. In addition to approved
medicines MabThera®/Rituxan® (rituximab), Gazyva®/Gazyvaro®
(obinutuzumab), and Venclexta®/Venclyxto(TM) (venetoclax) in
collaboration with AbbVie, Roche's pipeline of investigational
haematology medicines includes Tecentriq® (atezolizumab), an
anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596) and
a small molecule antagonist of MDM2 (idasanutlin/RG7388). Roche's
dedication to developing novel molecules in haematology expands
beyond malignancy, with the development of Hemlibra® (emicizumab),
a bispecific monoclonal antibody for the treatment of haemophilia
A.
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] Poon MC and
Lee A. Individualized prophylaxis for optimizing hemophilia care:
can we apply this to both developed and developing nations?
Thrombosis Journal. 2016; 14:32.
[2] De Kleijn P et al. Differences between developed and developing
countries in paediatric care in haemophilia. Haemophilia.
2012;18:94-100.
[3] Ghosh K, Ghosh K. Management of haemophilia in developing
countries: challenges and options. Indian J Hematol Bloos Transfus.
2016 July-Sept; 32(3):347-355.
[4] FDA. Hemlibra Prescribing Information. [Internet; cited 2019
Jan] Available from:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2017/761083s000lbl.pdf
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
Roche-Media-Release-WFH_Humanitarian-Aid-Program_EN