AMSTERDAM, July 6, 2017 /PRNewswire/ --
Positive Assessment in
Germany Brings More Patients
Closer to Gaining Access to
CINQAERO®
Teva Pharmaceuticals Europe BV, (NYSE and TASE: TEVA) today
announced that the German Federal Joint Committee (G-BA) has
confirmed CINQAERO® (reslizumab) provides evidence for a
minor additional benefit in patients with severe eosinophilic
asthma who were treated regularly with corticosteroids in addition
to the treatment for acute exacerbations.[1]
The decision is based on data from two phase 3 pivotal studies
(study 3082 and study 3083). For the sub-group of patients treated
with oral corticosteroids, the G-BA judged the studies to be
appropriate in order to derive evidence for a minor additional
benefit valid for the next three years. G-BA enables Teva to
commence reimbursement discussions with the National Association of
Statutory Health Insurance Physicians in Germany.
"Better times are finally on the horizon for patients with
severe asthma," stresses Prof. Dr. med. Johann Christian Virchow.
This is thanks to the fact that new biologics can achieve the
successful blockade of strategically important mediators in the
pathogenesis of asthma. There is also phenotype-specific treatment
available for both allergic and eosinophilic asthma. "This allows
targeted medications from which the individual patient can derive
the strongest benefit to be used," says the Rostock-based
pneumologist.
There are currently only limited treatment options available for
patients with severe eosinophilic asthma, and the condition can be
difficult to control, leading to life-threatening asthma
attacks,[2] impaired lung function
and quality of life, and possible
hospitalisations.[3] New targeted
treatments include biologics like CINQAERO®, that works
by targeting interleukin-5 (IL-5), a molecule shown to play a key
role in the symptoms of this type of severe
asthma.[4]
CINQAERO® was approved by the European Commission in
August 2016 as an add-on therapy in
adult patients with severe eosinophilic asthma, which is
inadequately controlled despite high-dose inhaled corticosteroids
plus another medicinal product for maintenance
treatment.[4]
"We welcome the positive assessment by the G-BA in Germany, which recognises the value that
CINQAERO® brings to people living with severe
eosinophilic asthma. We are excited that following this favourable
G-BA decision patients will be able to continue to access
CINQAERO® and we look forward to further positive
decision across Europe," said Luca
Frangoni, Head of Respiratory, Teva Pharmaceuticals Europe.
In adult patients with severe eosinophilic asthma who had
already received high-dose therapy with corticosteroids and further
medicinal products, the use of CINQAERO® led to a
decrease in asthma exacerbations, the relief of asthma-related
symptoms, as well as improvements in asthma control and
health-related quality of
life.[4]
In Europe, asthma affects 30
million people, 45% of whom have uncontrolled
asthma.[3] Approximately 5% of all
adult asthma patients have eosinophilic
asthma.[2]
References
- G-BA decision on reslizumab. Available at:
https://www.g-ba.de/informationen/nutzenbewertung/274/. Last
accessed: July 2017.
- de Groot JC., ten Brinke A. and Bel EHD. Management of the
patient with eosinophilic asthma: a new era begins. ERJ Open
Res. 2015; 1 (1) 00024-2015; DOI:
10.1183/23120541.00024-2015.
- Price, D., Fletcher, M., & Molen, T. V. Asthma control and
management in 8,000 European patients: The REcognise Asthma and
LInk to Symptoms and Experience (REALISE) survey. 2014. Npj
Prim. Care Resp Med. 24,14009. doi:10.1038/npjpcrm.2014.9.
Available at:
http://www.nature.com/articles/npjpcrm20149#references. Last
accessed: July 2017.
- CINQAERO® Summary of Product Characteristics.
Available at:
http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/003912/WC500212250.pdf.
Last accessed: July 2017.
About Teva Respiratory
Teva Respiratory develops and delivers high-quality treatment
options for respiratory conditions, including asthma, COPD, cystic
fibrosis and allergic rhinitis. The Teva Respiratory portfolio is
centred on optimising respiratory treatment for patients and
healthcare providers through the development of novel delivery
systems and therapies that help address unmet needs. The company's
respiratory pipeline and clinical trial program are based on drug
molecules delivered in proprietary dry powder formulations and
breath-activated device technologies, as well as a targeted
biologic treatment for severe asthma. Through research and clinical
development, Teva Respiratory continually works to expand,
strengthen and build upon its treatment portfolio to positively
impact the lives of the millions of patients living with
respiratory disease.
About Teva
Teva is among the top 15 global pharmaceutical companies
globally, delivering high-quality, patient-centric healthcare
solutions used by approximately 200
million patients in 100 markets every day. Teva
produces a leading innovative treatment for multiple sclerosis and
has late-stage development programs for a range of
disorders of the central nervous system, including movement
disorders, migraine, pain and neurodegenerative conditions. With
its European headquarters in Amsterdam,
the Netherlands, Teva is the world's largest generic
medicines producer, leveraging its portfolio of more than 1,800
molecules to produce a broad range of products in nearly every
therapeutic area. Teva draws on its specialty and generics
capabilities to seek new ways of addressing unmet patient needs by
combining drug development with devices, services and
technologies. Teva's net revenues in 2016 were $21.9 billion. For more information,
visit http://www.tevapharm.com.