Mundipharma today announced the positive European Commission (EC) decision for flutiform(R) (fluticasone propionate/formoterol fumarate), a new combination therapy for the maintenance treatment of asthma, in Europe. This decision is binding on all 21 Concerned Member States involved in the decentralized procedure (DCP) and the first national approvals of flutiform are expected across a number of countries by the end of 2012.
The combination of fluticasone propionate (fluticasone), an inhaled corticosteroid (ICS), and formoterol fumarate (formoterol), a long-acting beta2-agonist (LABA) therapy is delivered via a single aerosol inhaler for the first time. flutiform will be indicated for the regular treatment of asthma in patients aged 12 years and over (50/5microg and 125/5microg strengths) and in adults (250/10microg strength) whose symptoms are not adequately controlled on an ICS and an as-required inhaled short-acting beta2-agonist (SABA), and in those patients who are already receiving treatment with both an ICS and LABA.
"Asthma still represents an important clinical challenge despite current available treatments," said Alberto Papi, Professor of Respiratory Medicine, University of Ferrara, Italy. "With flutiform, the characteristics of two very effective asthma medications are combined for the first time in a single inhaler: a potent inhaled corticosteroid, fluticasone, and a fast-acting LABA, formoterol. The pharmacological characteristics of this combination offer an important treatment option for patients with asthma."
"We welcome the decision of the European authorities and consider this a significant step in establishing Mundipharma's presence in the respiratory market," said Antony Mattessich, Regional Director Europe, Mundipharma. "Asthma is a serious public health issue, affecting approximately 30 million people in Europe, and we are committed to the research and development of new treatment solutions for this debilitating condition."
This EC decision follows the positive opinion of the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) announced on 20 April 2012.
Mundipharma International Limited is licensed by Jagotec AG, a SkyePharma Group company, as the authorised distributor of the fluticasone/formoterol combination for Europe and most other territories outside Japan and the Americas.
Clinical evidence behind flutiform(R)
The EC recommendation was granted based on a regulatory package of eight phase I/II studies and nine phase III trials, which were conducted in a patient population of nearly 4,500, of whom 1,900 received flutiform.
The phase III clinical trials have demonstrated the efficacy, safety and tolerability profile of flutiform across a range of asthma severities and in comparison with two currently available combination therapies for asthma (fluticasone/salmeterol and budesonide/formoterol).[1,2,3,4]
Phase III clinical trial data (8-12 weeks) demonstrated that the new combination:
- is more effective in improving asthma symptom scores, including an improvement in the percentage of symptom-free days and awakening-free nights, compared with a similar dose of fluticasone alone
- provides similar improvements in lung function parameters, control of asthma symptoms and similar level of exacerbations compared to its individual components administered concurrently via separate inhalers
- has a more rapid onset of bronchodilatory action than the fluticasone/salmeterol combination as defined by the first time point post-dose at which FEV1 was at least 12 percent greater than the pre-dose value. The superiority of fluticasone/formoterol combination (100/10 or 250/10 mug b.i.d.) compared to the fluticasone/salmeterol combination (100/50 or 250/50 mug b.i.d.) was shown over a 12-week study period (HR 1.64)
- has a safety and tolerability profile similar to that of its individual components administered concurrently via separate inhalers
1. flutiform SmPC
2. Bodzenta-Lukaszyk A, R Buhl, et al. Eur Respir J 2011a;38:153s
3. Bodzenta-Lukaszyk A, Dymek A et al. BMC Pulm Med J. 2011;11:28
4. Bodzenta-Lukaszyk A, Pulka et al. Respir Med J. 2011;105(5):674-82