Teva receives EU Marketing Authorisation for Seffalair® Spiromax® and BroPair® Spiromax® (salmeterol xinafoate / fluticasone propionate)

Teva Pharmaceuticals Europe announced that it has received EU Marketing Authorisation for Seffalair Spiromax and its duplicate BroPair Spiromax (salmeterol xinafoate/ fluticasone propionate, 12.75/100 and 12.75/202 micrograms delivered doses) as a maintenance treatment for asthma in adults and adolescents aged 12 years and older. Initial launches are planned in Portugal, Switzerland, Spain and the UK.

Introducing Seffalair Spiromax and BroPair Spiromax

The launch of Seffalair Spiromax and BroPair Spiromax further extends Teva’s respiratory portfolio, and provides healthcare professionals another option in treating people living with asthma. Since the launch of DuoResp® Spiromax® (budesonide/formoterol), the Spiromax® inhaler has been well received by healthcare professionals and patients.^1,2

Inhaler technique and treatment adherence are key factors in improving outcomes for asthma patients, of which there are an estimated 28 million in the EU.^3,4

"We are excited about the European approval of Seffalair Spiromax and BroPair Spiromax, as an important goal of our respiratory franchise is to bring new treatment options to healthcare professionals who support people living with long-term conditions such as asthma,” says Paul Blonk, Head of Teva Respiratory Europe. “We want to empower patients to effectively manage their condition through the medicines we provide, whilst also offering cost-effective treatments to healthcare systems.”

About Seffalair Spiromax and BroPair Spiromax (salmeterol xinafoate / fluticasone propionate)

Seffalair Spiromax and BroPair Spiromax are indicated as a regular treatment for asthma in adults and adolescents aged 12 years and older not adequately controlled with inhaled corticosteroids and ‘as needed’ inhaled short-acting β2 agonists.

About Teva Respiratory

Teva Respiratory develops and delivers high-quality treatment options for respiratory conditions, including asthma, COPD and cystic fibrosis. The Teva Respiratory portfolio is centred on optimizing respiratory treatment for patients and healthcare providers through the development of novel delivery systems and therapies that help address unmet needs. Teva’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 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 Pharmaceuticals Europe makes life-saving and life-improving medicines more accessible for millions of people around the world. We focus on treatments for migraine, conditions of the central nervous system including pain, as well as respiratory conditions like asthma and COPD and have a portfolio in oncology. Our mission is to be a global leader in generics and biopharmaceuticals improving the lives of patients around the globe.

Building on more than a century-old legacy we have an established presence in generics, specialty, over-the-counter (OTC) and active pharmaceutical ingredients (API). With a fully integrated R&D function, strong operational base and global infrastructure and scale we invest millions of dollars to help our scientists find the next breakthrough.

We strive to act in a socially and environmentally responsible way. Headquartered in Israel, with production and research facilities around the globe, we employ 40,000 professionals, committed to improving the lives of millions of patients. Learn more at www.tevapharm.com.

References

1. van der Palen et al. Poster presented at the ERS International Congress, Paris, France, September 2018 (PA1020).
2. Roche N, et al. J Asthma, 2021; DOI: 10.1080/02770903.2021.1875482
3. GBD. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018. 392 (10159):1789-858.
4. Eurostat. First population estimates.

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Contact information

PR (Europe)
Fiona Cohen, + 31 6 2008 2545