flutiform® Receives a Positive Opinion in Europe for the Treatment of Children with Asthma
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).
Notes to editors:
For medical and pharmaceutical trade media only
For further information please visit:
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.
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.
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
Communications Lead, Mundipharma International Ltd
Tel: +44 (0) 7773 199 422
Account Director, Havas SO
Tel: +44 (0) 7983 128 712
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
Abu Dhabi to Host Interfaith Alliance For Safer Communities: Child Dignity in the Digital World Forum on 19 November17.11.2018 13:40 | Pressemelding
Held under the patronage of His Highness Sheikh Mohammed bin Zayed Al Nahyan, Crown Prince of Abu Dhabi and Deputy Supreme Commander of the UAE Armed Forces, the UAE will host the first edition of the Interfaith Alliance For Safer Communities Forum on November 19-20 in recognition of the country’s leading role in promoting tolerance and interfaith dialogue. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20181117005008/en/ His Highness Sheikh Mohammed bin Zayed Al Nahyan, Crown Prince of Abu Dhabi and Deputy Supreme Commander of the UAE Armed Forces (Photo: AETOSWire) The forum will host 450 guests including religious leaders, NGOs and heads of industry to discuss ongoing social challenges and develop comprehensive solutions for protecting youth from cybercrime. The Interfaith Alliance For Safer Communities Forum is an expansion of the Child Dignity in the Digital World Congress which was held in October 2017 in the Vatican, an
Philip Morris International and Dorna Switch Gears in Quest for a World without Tobacco Smoke17.11.2018 11:00 | Pressemelding
Philip Morris International Inc. (PMI) (NYSE:PM) and Dorna Sports S.L., the commercial rights holder for the world FIM MotoGP Championships, have extended their partnership until the end of 2021. The two organizations have collaborated successfully for 26 years. As of 2019, the partnership will focus on advancing the cause of a smoke-free world. More than 1 billion people smoke today and, according to the World Health Organization, will continue to smoke in the near future. PMI has committed to transform its business and encourage all men and women who would otherwise continue smoking to replace cigarettes with better alternatives as soon as possible. With around 350 million MotoGP fans worldwide, MotoGP can play a significant role in positively impacting the lives of people who smoke and those around them. “The best choice for consumers concerned about the health risks of smoking is to quit tobacco and nicotine altogether. Today, however, technology, science and innovation provide a r
Schlumberger Announces Fourth-Quarter and Full-Year 2018 Results Conference Call16.11.2018 18:00 | Pressemelding
Schlumberger Limited (NYSE:SLB) will hold a conference call on January 18, 2019 to discuss the results for the fourth quarter and full year ending December 31, 2018. The conference call is scheduled to begin at 8:30 am US Eastern time and a press release regarding the results will be issued at 7:00 am US Eastern time. To access the conference call, listeners should contact the Conference Call Operator at +1 (800) 288-8967 within North America or +1 (612) 333-4911 outside of North America approximately 10 minutes prior to the start of the call, and ask for the “Schlumberger Earnings Conference Call.” A webcast of the conference call will be broadcast simultaneously at www.slb.com/irwebcast on a listen-only basis. Listeners should log in 15 minutes prior to the start of the call to test their browsers and register for the webcast. Following the end of the conference call, a replay will be available at www.slb.com/irwebcast until February 18, 2019, and can be accessed by dialing +1 (800)
Visa Strengthens Commitment to Growing Digital Payments in India16.11.2018 14:33 | Pressemelding
Visa (NYSE: V) today announced a minority investment in BillDesk, a leading platform for online payments and bill payments in India. Visa’s investment and collaboration will help BillDesk develop new product lines for its payments and loyalty businesses and also expand its footprint into other geographies. The investment will be subject to necessary statutory approvals and is expected to have no direct bearing on Visa’s existing Indian business. “As a leading payments player in India, BillDesk has been a long time business partner to Visa. Having worked with BillDesk’s founders over the years, the Visa leadership has been consistently impressed with their vision, market knowledge and execution capabilities, as well as alignment on values. This investment further reinforces our long-term commitment to India’s digital payments growth story,” said Asia Pacific regional president, Chris Clark. “We are truly excited by this investment from the world's largest global payment network, Visa. W
Guidewire Enhances PartnerConnect Consulting Program with Addition of Product and Regional Specializations16.11.2018 13:55 | Pressemelding
Guidewire Software, Inc. (NYSE: GWRE), provider of the industry platform Property and Casualty (P&C) insurers rely upon, today announced the addition of specializations to its PartnerConnect Consulting program. Specializations have been added to aid insurance companies in selecting the best partner to lead or staff their Guidewire projects. Guidewire unveiled new specializations, including two which have been successfully piloted earlier this year. “Our customers will now have more clarity and information as to which partners have the proven capabilities in their chosen product and region,” said Lisa Walsh, vice president, Alliances, Guidewire Software. “Adding these specializations will also allow us to have more insight into a partner’s performance and competencies.” To earn a specialization, partners need to demonstrate skills, knowledge, and competency in a specific Guidewire product or solution by certifying staff at multiple levels (specialist and professional) through Guidewire’
Janssen receives positive CHMP opinion for ERLEADA™ (apalutamide) for patients with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic disease16.11.2018 13:15 | Pressemelding
The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for apalutamide, a next generation oral androgen receptor inhibitor for the treatment of adult patients with non-metastatic castration-resistant prostate cancer (nmCRPC) who are at high risk of developing metastatic disease.2 The CHMP’s positive opinion will now be reviewed by the European Commission (EC), which has the authority to grant approval for the use of apalutamide. The CHMP’s positive opinion is based on data from the pivotal SPARTAN Phase 3 clinical study which assessed the safety and efficacy of apalutamide versus placebo in patients with nmCRPC who have a rapidly rising prostate specific antigen (PSA) level despite receiving continuous androgen deprivation therapy (ADT). The SPARTAN clinical study showed that apalutamide, when added to ADT, significantly reduced the risk