CAMBRIDGE, England, March 30, 2016 /PRNewswire/ --
Mundipharma announced today that they have submitted a file to the UK regulatory authority, the Medicines and Healthcare products Regulatory Agency (MHRA) seeking a licence for its new product flutiform® K-Haler®. The indication sought is for the treatment of asthma in adults and adolescents where the use of a combination product (ICS and LABA) is appropriate. The file will be reviewed through the decentralised procedure (DCP), one of the routes to obtain marketing authorisation for medicines in Europe.
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The K-Haler® is a novel pMDI (pressurised metered dose inhaler) device, which has a simple breath-activated mechanism, and has been designed to make it easier for patients to use correctly. Incorrect inhaler technique coupled with poor adherence to therapy are considered common causes of uncontrolled asthma.[1],[2]
"The regulatory submission for flutiform K-Haler demonstrates our continued commitment to improve outcomes for patients with asthma by expanding our portfolio" said Antony Mattessich, Regional Director of Europe at Mundipharma. "The K-Haler device is a new platform technology, that is designed to be suitable for a range of Respiratory products."
The flutiform® K-Haler® contains the same combination of fluticasone propionate and formoterol fumarate as Mundipharma's existing asthma maintenance combination treatment, flutiform pMDI. The efficacy and safety of flutiform® is supported by extensive clinical evidence[3],[4],[5],[6]. flutiform® now has real-world use for up to three years across Europe and Asia-Pacific regions.
Mundipharma have listened to patients and doctors to understand the day-to-day challenges of managing respiratory diseases. Our drug delivery expertise and approach to provide a range of patient focused solutions is aimed at helping to improve outcomes and enable people with respiratory diseases to breathe better.
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About Mundipharma
The Mundipharma network of independent associated companies consists of privately owned companies and joint ventures covering the world's pharmaceutical markets. The Mundipharma network has a presence in 51 countries with more than 7,800 employees across the world. These companies are committed to bringing to patients the benefits of pioneering treatment options in the core therapy areas of pain management, oncology, respiratory and inflammatory conditions.
Through innovation, design and acquisition, the Mundipharma network of independent associated companies delivers important treatments to meet the most pressing needs of patients, healthcare professionals and health systems worldwide.
About flutiform®
In Europe, flutiform is licensed for the regular treatment of asthma in patients aged 12 years and over when use of a combination product (an inhaled corticosteroid [ICS] and a long-acting β2-agonist [LABA]) is appropriate: for patients not adequately controlled with an ICS and an 'as required' inhaled short-acting β2-agonist or for patients already adequately controlled on both an ICS and a LABA. It is available in 20 countries across Europe including the UK, Germany, France, Spain, Netherlands and Italy.
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.[7]
About Skyepharma
Skyepharma combines proven scientific expertise with validated proprietary drug delivery technologies to develop innovative oral and inhalation pharmaceutical products. The Group is eligible for revenues from 16 approved products in the areas of inhalation, oral, topical and injectable drug delivery as well as generating income from the development of further products and technology licenses. The products developed by the Group are marketed throughout the world by big pharma as well as speciality pharmaceutical companies. For more information, visit http://www.skyepharma.com. flutiform is a registered trade mark of Jagotec AG.
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