06.07.2017 – 18:17
German Federal Joint Committee (G-BA) Confirms Evidence for Additional Benefit for CINQAERO® (reslizumab) in Severe Asthma Patients with an Elevated Eosinophil Count
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.
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, impaired lung function and quality of life, and possible hospitalisations. 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.
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.
"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.
In Europe, asthma affects 30 million people, 45% of whom have uncontrolled asthma. Approximately 5% of all adult asthma patients have eosinophilic asthma.
1. G-BA decision on reslizumab. Available at: https://www.g-ba.de/informationen/nutzenbewertung/274/. Last accessed: July 2017. 2. 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. 3. 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. 4. CINQAERO® Summary of Product Characteristics. Available at: http:/ /www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Info rmation/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.
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.
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