Teva receives EU Marketing Authorisation for Seffalair® Spiromax® & BroPair® Spiromax® (salmeterol xinafoate / fluticason...
08 April 2021 - 5:00PM
Business Wire
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
- van der Palen et al. Poster presented at the ERS International
Congress, Paris, France, September 2018 (PA1020).
- Roche N, et al. J Asthma, 2021; DOI:
10.1080/02770903.2021.1875482
- 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.
- Eurostat. First population estimates.
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