The European Commission ( EC ) has granted marketing authorisation for Flutiform ( Fluticasone propionate / Formoterol fumarate ), a new combination therapy for the maintenance treatment of asthma, in Europe.
The combination of Fluticasone propionate, an inhaled corticosteroid ( ICS ), and Formoterol fumarate, a long-acting beta2-agonist ( LABA ) therapy is delivered via a single aerosol inhaler for the first time.
Flutiform is indicated for the regular treatment of asthma in patients aged 12 years and over ( 50/5 mcg and 125/5 mcg strengths ) and in adults ( 250/10 mcg strength ) whose symptoms are not adequately controlled on an inhaled corticosteroid and an asrequired inhaled short-acting beta2-agonist ( SABA ), and in those patients who are already receiving treatment with both an inhaled corticosteroid and LABA.
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 ).
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 / Ssalmeterol combination as defined by the first time point post-dose at which FEV1 was at least 12% greater than the pre-dose value. The superiority of Fluticasone / Formoterol combination ( 100/10 or 250/10 mcg b.i.d. ) compared to the Fluticasone / Salmeterol combination ( 100/50 or 250/50 mcg b.i.d. ) was shown over a 12-week study period ( hazard ratio, HR=1.64 );
- has a safety and tolerability profile similar to that of its individual components administered concurrently via separate inhalers. ( Xagena )
Source: Mundipharma, 2012