Business Wire

flutiform® Receives a Positive Opinion in Europe for the Treatment of Children with Asthma

Share

The Mundipharma network of independent associated companies today announced that the European Decentralised Procedure (DCP) licence variation application for flutiform ® , extending the indication to the treatment of asthmatic children, has closed with a positive opinion. flutiform ® is a combination of fluticasone propionate and formoterol in a single pressurised metered dose inhaler (pMDI), otherwise known as a press and breathe aerosol inhaler. It is now indicated at a dose of two puffs (actuations) 50/5 µg for regular twice-daily, maintenance treatment of asthma in children aged 5 to <12 years when a combination of an inhaled corticosteroid (ICS) and a long-acting β2-agonist (LABA) is appropriate.1

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181108005407/en/

flutiform ® has been available in Europe for the treatment of asthma in adults and adolescents (≥12 years old) since 2012 and has a tolerability profile supported by extensive clinical evidence and real-world use for six years across Europe and Asia-Pacific regions in this age group.1,4,5,6,7

“We are delighted that the combination aerosol flutiform ® has now been licenced for use in children aged 5 to <12 years in addition to the current indication for adolescents and adults,” said Catriona Cutting, Head of Regulatory Strategy, Mundipharma. “Asthma affects all aspects of children’s and their families’ lives and new treatment options for paediatric asthma are still very much needed.”

Asthma is the most common chronic disease in childhood2 and represents a major health burden.8 Despite the availability of several paediatric treatment options, uncontrolled asthma is still common in children3 and morbidity from the condition is a major health burden for patients, their families and society.8 Poorly controlled asthma in children is associated with time off school, exacerbations and days in hospital.9 Recent studies suggest that poor asthma control may have a greater impact on children than previously thought, including important long-term consequences such as an increased risk of lifestyle-associated diseases and poorer school performance.10

“The paediatric licence indication for flutiform ® is part of Mundipharma’s commitment to provide new treatments to help improve the lives of people affected by asthma,” said Alberto Martinez, President and CEO, Mundipharma International. “The use of this combination is now well established in adults and adolescents, and we are delighted that following this positive opinion we will also be able to offer this combination for the treatment of paediatric patients.”

The licence variation of flutiform ® for use in children was based on efficacy and safety data from two 12-week paediatric studies, which demonstrated that the treatment administered as two puffs (actuations) of 50/5 μg dose b.i.d., was non-inferior on lung function endpoints to the established combination therapy, fluticasone propionate/salmeterol, and had a similar tolerability profile. In addition, during a 24-week extension phase of one of the studies, lung function improvements compared with baseline were sustained.11 The 24-week extension phase also showed that children receiving flutiform ® had growth rates and plasma cortisol levels within the normal ranges. A 28-day knemometry study further found that flutiform ® did not suppress lower leg growth rate compared with baseline.11

flutiform ® is an easy-to-use inhaler, which can be used effectively with or without a spacer (use of a spacer is advised for children who may find coordination of actuation with inspiration difficult).12 The recommended dose of flutiform ® in children is two puffs (actuations) 50/5 µg twice daily (BID).

-Ends-

Notes to editors:

For medical and pharmaceutical trade media only

For further information please visit:

http://www.mundipharma.com/Press/RespiratoryResources/background

http://www.flutiform.com/medical-media

About the Mundipharma network

The Mundipharma global network of privately-owned independent associated companies was founded in 1956 by doctors, and now operates in over 120 countries worldwide. We are focused on developing business partnerships to identify and accelerate meaningful technology across an increasingly diverse portfolio of therapy areas including respiratory, diabetes, oncology, pain, and biosimilars. Consistent with our entrepreneurial heritage, we like to think we see what others don’t by challenging conventional wisdom and asking different and challenging questions. By working in partnership with all our stakeholders, the Mundipharma global network develops medicines that create value for patients, payers and wider healthcare systems.

For more information please visit: www.mundipharma.com .

About flutiform ®

In Europe, flutiform ® is licenced for regular twice-daily, maintenance treatment of asthma in patients aged 5 years and over when use of a combination product (an inhaled corticosteroid [ICS] and a long-acting β2-agonist [LABA]) is appropriate. As of November 2018, it is available in 21 countries across Europe including the UK, Germany, France, Spain and Italy. flutiform ® is available in 50/5μg strength for children aged 5 to <12 years, in 50/5μg and 125/5μg strengths for adults and adolescents and 250/10μg strength for adults only.

About asthma

Asthma is a chronic inflammatory disorder of the airways which leads to recurrent episodes of wheezing, breathlessness, chest tightness and coughing. Patients with poorly managed asthma are at an increased risk of exacerbations, hospitalisation and death. Poorly managed asthma can also have a huge impact on a person’s quality of life and day-to-day activities.13

® FLUTIFORM is a registered trade mark of Jagotec AG and is used under licence.

References:

1 flutiform ® Summary of Product Characteristics

2 Lung Health in Europe. Facts and Figures. European Lung Foundation 2013 http://www.europeanlung.org/assets/files/publications/lung_health_in_europe_facts_and_figures_web.pdf

3 Byrne P, et al. The Poorly Explored Impact of Uncontrolled Asthma. CHEST 2013. 143(2) 511-523

4 Bodzenta-Lukaszyk A, R Buhl, et al. Fluticasone/formoterol combined in a single aerosol inhaler vs budesonide/formoterol for the treatment of asthma: a non-inferiority trial. Eur Respir J 2011a;38:153s

5 Bodzenta-Lukaszyk A, Dymek A et al. Fluticasone/formoterol combination therapy is as effective as fluticasone/salmeterol in the treatment of asthma, but has a more rapid onset of action: an open-label, randomized study. BMC Pulm Med J. 2011;11:28

6 Bodzenta-Lukaszyk A, Pulka et al. Efficacy and safety of fluticasone and formoterol. Respir Med J. 2011;105(5):674-82

7 Backer V, et al. Real-world study to evaluate the safety and effectiveness of fluticasone propionate/formoterol (FP/FORM) in patients with asthma. Abstract FLT9503, European Respiratory Society (ERS) 2017, Milan

8 European Respiratory Society. Childhood asthma. The European Lung White Book. 2013

9 Asher, et al. Global burden of asthma among children. Int J Tuberc Lung Dis 2014. 18(11):1269–1278

10 Pedersen S. Asthma control in children: Is it important and can we measure it? Paediatr Respir Rev 2016; 17:36-8. doi: 10.1016/j.prrv.2015.08.009. Epub 2015 Oct 31. https://www.ncbi.nlm.nih.gov/pubmed/26531216

11 Wolthers O, et al. Short-Term Growth During Treatment with Inhaled Fluticasone Propionate/Formoterol, Fluticasone and Beclomethasone Treatment 2017. J Aerosol Med Pulm Drug Deliv. 2017 Oct;30(5):373-380

12 GINA, Global Strategy for Asthma Management and Prevention 2018

13 Raimundo K, et al. Relationships between asthma control, productivity and health outcomes in a US survey. European Resp J 2016 48: PA4219; DOI: 10.1183/13993003.congress-2016.PA4219

Contact information

Tiffany Fretwell
Communications Lead, Mundipharma International Ltd
E-mail: Tiffany.Fretwell@mundipharma.com
Tel: +44 (0) 7773 199 422
or
Nicola Lilley
Account Director, Havas SO
E-mail: Nicola.Lilley@HavasSO.com
Tel: +44 (0) 7983 128 712

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

World’s Leading Mobile Operators to Disclose Climate Impacts as Part of New GSMA-Led Climate Action Roadmap16.9.2019 12:00:00 EESTPress release

Many of the world’s largest mobile operator groups have agreed to start disclosing their climate impacts as part of a major new GSMA-led initiative to develop a mobile industry climate action roadmap in line with the Paris Agreement. More than 50 mobile operators – which together account for more than two thirds of mobile connections globally1 – are now disclosing their climate impacts, energy and greenhouse gas (GHG) emissions via the internationally recognised CDP global disclosure system. The move will enable full transparency for investors and customers involved in the mobile sector. Many of the companies are disclosing for the first time as part of the GSMA-led initiative. GSMA operator members that are disclosing via CDP include América Móvil, AT&T Inc., Axiata Group, Bell Canada, Bharti Airtel, BT Group, China Mobile, China Telecom, China Unicom, Chunghwa Telecom, Deutsche Telekom, DNA Plc, Elisa Corporation, Far EasTone, Globe Telecom, Inmarsat, KDDI Corporation, KPN, KT Corpor

GSMA GLOMO Awards 2020 Now Open for Entries16.9.2019 11:00:00 EESTPress release

The GSMA today announced that the Global Mobile Awards 2020 (GLOMO Awards) are now open for entries. The prestigious awards, which will enter their twenty-fifth year at GSMA MWC Barcelona 2020, celebrate the key innovations and achievements from both individuals and organisations across the mobile industry. Over 300 judges, comprised of analysts, journalists and academics, will assess 9 categories and 37 different awards that reflect the key achievements to have shaped the industry over the past 12 months. Entries for the 2020 awards may be submitted now, with the winners announced at a ceremony held at GSMA MWC Barcelona. “The GLOMOS will celebrate a quarter-century of innovation at MWC Barcelona next year. It is incredible to think that in 1995 we welcomed the world’s first flip phone and today we are about to experience the first 5G-enabled, foldable smartphone,” said Mats Granryd, Director General, GSMA. “This is a fast-moving, ever-changing industry where mobile connectivity is im

GSMA Announces First Speakers for Mobile 360 – Eurasia 201916.9.2019 11:00:00 EESTPress release

The GSMA today announced the first speakers for its Mobile 360 – Eurasia 2019 conference, which will take place on the 8-9 October 2019 at the Lotte Hotel, Moscow. The event, which is now in its second year, invites senior leaders from mobile operators, governments and regulatory bodies to discuss the impact of mobile technology on the digital economy in the region. This year’s event will have the theme of ‘Embracing 5G and Emerging Technologies to Accelerate the Digital Economy’ and will examine the imminent commercial launch of 5G in the region. Initial commercial 5G launches are expected in 2020 with the total number of 5G connections in Russia set to reach 48 million by 2025. “We are excited to be hosting our second Mobile 360 event in Russia and have convened an incredibly strong line-up of keynote speakers from across the world who will discuss the pivotal role that 5G networks will play in the digital economy,” said Mats Granryd, Director General, GSMA. “5G will be a key focus a

Jefferies to Hold Global Relief Day in Support of Hurricane Relief in the Bahamas Today, September 1616.9.2019 10:00:00 EESTPress release

Jefferies announced that today is the firm’s global trading day for Hurricane Dorian relief efforts in the Bahamas. Jefferies will offer investors around the world the opportunity to join efforts to assist those affected by the devastation of this event by trading with Jefferies. As previously announced, Jefferies will donate all net trading commissions earned today from U.S., European and Asia equity, fixed income and foreign exchange trading. In addition, Jefferies as a firm will donate $1 million itself directly, and all 3,656 employees worldwide will be given the opportunity to donate to the relief effort their salary for today. These contributions will be allocated to a series of charities with the goal of quickly getting funds to relief activities directly involved in the rescue and recovery efforts. Rich Handler, Chairman and Chief Executive Officer of Jefferies, and Brian Friedman, Chairman of the Executive Committee, commented: "All of us at Jefferies are deeply concerned abou

Velodyne Shows Velarray Lidar in Sleek Car Designs at IAA 2019 Conference14.9.2019 22:39:00 EESTPress release

Velodyne Lidar, Inc. (Hall 8.0, Booth A13) is showcasing the pristine integration of Velarray lidar sensors into consumer vehicles to make currently available, high-end electric vehicles safer at the IAA 2019 Conference. Velodyne has addressed the market need for lidar technology that enables high-level Advanced Driver Assistance Systems (ADAS) for safe navigation and collision avoidance, all within a compact form factor. The lidar is situated behind the vehicle’s windshield for streamlined, flawless integration. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190914005023/en/ Can you see the lidar? The Velarray is embedded in a sleek electric car at IAA 2019 (Hall 8.0, Booth A13). (Photo: Velodyne Lidar) Velodyne booth visitors can see how the Velodyne Velarray™ sensors are beautifully integrated into sleek, high-end vehicles, maintaining their aerodynamic design. The Velarray’s small, embeddable form factor is a powerful so

Insurance Leaders and Visa Digitize Claims Payouts for Individuals and Businesses When They Need It Most13.9.2019 17:37:00 EESTPress release

Emergencies like car collisions or natural disasters come when people least expect them, leaving individuals unprepared to complete insurance forms, confirm claim estimates, and pay repair shop and medical expenses. During these times, quick access to funds is critical. Visa is committed to working with innovative companies in the insurance industry to help turn outdated and time-consuming processes associated with insurance claim payouts into near real-time1 access to payments when individuals, families and businesses need them the most. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20190913005323/en/ Visa Direct powers real-time insurance payouts, providing people access to their funds when they need it most. (Graphic: Business Wire) “Visa believes that money shouldn’t be a stressor in moments of crisis and waiting on average six to 10 days to access the money from insurance checks, is outdated, frustrating and costly to th

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom