EU Marketing Authorization Granted for Teva's Aerivio Spiromax® (fluticasone/salmeterol 500/50)

AMSTERDAM, September 30, 2016 /PRNewswire/ --

Approval of hybrid high-dose fluticasone/salmeterol maintenance treatment for people living with severe asthma and COPD, delivered via the award-winning Spiromax® inhaler to help patient usability 

Teva Pharmaceutical Industries Ltd., announced today that it has received EU Marketing Authorization for Aerivio Spiromax^® (fluticasone/salmeterol 500/50)^[1] as a maintenance bronchodilator treatment for adult patients with severe asthma and chronic obstructive pulmonary disease (COPD). Aerivio Spiromax^® contains a fixed dose combination of fluticasone propionate, an inhaled corticosteroid to treat the underlying inflammation in asthma and COPD, and salmeterol xinafoate, a long-acting beta-agonist, being delivered via the award-winning^[2] Spiromax^® inhaler.

"We are excited about the European approval of Aerivio Spiromax^® that can give patients with severe asthma and COPD the possibility to benefit from this widely used fixed dose combination in the award-winning Spiromax^® inhaler," said Luca Frangoni, VP Head of Respiratory Europe. "It is an important goal of our growing respiratory franchise to bring a wide range of new treatment options to patients and healthcare professionals; from innovative treatments and value-adding services to advanced inhalers such as Spiromax^®."

The Spiromax^® inhaler has received a Medical Design Excellence Award that recognizes significant advances in medical product design. The inhaler is primed by opening the cover and a click confirms it is ready for use. It provides dosing confirmation for patients through a subtle taste and precise dose indicator. Spiromax^® delivers consistent dosing of the medicines from first dose to last.

With the approval of Aerivio Spiromax^®[1] Teva adds another established fixed dose combination of ICS/LABA (inhaled corticosteroid with long-acting beta-agonist) to its inhaler family. DuoResp Spiromax^®, the combination of budesonide and formoterol fumarate dihydrate, already received EU marketing authorization for the treatment of asthma and COPD in May 2014.

About asthma and COPD
More than 16 million young adults (15-45 years) in Europe are estimated to have asthma.^[3] Of these, 5-10% have severe asthma,^[4] and the burden of cost and lost productivity is highest for this group.^[5] A further 23 million adults suffer from COPD, with poor control resulting in up to 1.1 million hospital admissions each year.^[4] More than 90% of patients make inhalation technique errors, and poor technique is associated with poor disease control.^[6],[7]

About Aerivio Spiromax®
Aerivio Spiromax^® (fluticasone/salmeterol 500/50) is indicated as a maintenance bronchodilator treatment for adult patients with severe asthma and chronic obstructive pulmonary disease (COPD). Aerivio Spiromax^® contains a high-strength formulation of salmeterol xinafoate, a selective long-acting inhaled β adrenoceptor agonist, and fluticasone propionate, an inhaled glucocorticoid with anti-inflammatory activity in the lungs. This formulation is delivered via the award-winning^[2] Spiromax^® inhaler. National launches will take place in selected markets over the coming months. See the Summary of Product Characteristics (SmPC) for full prescribing information.

About Teva Respiratory
Teva Respiratory develops and delivers high-quality treatment options for respiratory conditions, including asthma, COPD and allergic rhinitis. The Teva Respiratory portfolio is centered on optimizing 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-actuated device technologies, as well as a targeted biologics. 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 Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is a leading global pharmaceutical company that delivers high-quality, patient-centric healthcare solutions used by millions of patients every day. Headquartered in Israel, Teva is the world's largest generic medicines producer, leveraging its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, Teva has a world-leading position in innovative treatments for disorders of the central nervous system, including pain, as well as a strong portfolio of respiratory products. Teva integrates its generics and specialty capabilities in its global research and development division to create new ways of addressing unmet patient needs by combining drug development capabilities with devices, services and technologies. Teva's net revenues in 2015 amounted to $19.7 billion. For more information, visit http://www.tevapharm.com.

References 

1.    European Medicines Agency, Aerivio Summary of Product Characteristics. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002752/WC500212329.pdf  Date accessed: September 2016

2.    Medical Design Excellence Awards 2015. Silver award winner, Drug-Delivery Devices and Combination Products category. Available from: http://mdeawards.mddionline.com/2015-winners . Date accessed: September 2016

3.    European Lung White Book 2013, Online Edition - Chapter 1, http://www.erswhitebook.org/chapters/the-burden-of-lung-disease . Date accessed: September 2016.

4.    Wenzel S. American Journal of Respiratory and Critical Care Medicine. 2005;172(2):149-60, DOI: 10.1164/rccm.200409-1181PP

5.    Antonicelli L, Bucca C, Neri M, et al. European Respiratory Journal. 2004;23(5):723-9, DOI: 10.1183/09031936.04.00004904

6.    Giraud V, Roche N. European Respiratory Journal. 2002;19(2):246-51, DOI: 10.1183/09031936.02.00218402

7.    Melani AS, Bonavia M, Cilenti V, et al. Respiratory Medicine. 2011;105(6):930-8, DOI: 10.1016/j.rmed.2011.01.005