EMA approves Flutiform (Mundipharma) for Asthma treatment - 05-Jul-2012

The EMA has approved Flutiform (fluticasone plus formoterol), from Mundipharma, for the maintenance treatment of Asthma. This decision is binding on all 21 Concerned Member States involved in the decentralised procedure and the first national approvals of Flutiform are expected across a number of countries by the end of 2012. It is indicated for the regular treatment of Asthma in patients aged 12 years and over and in adults 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. Approval 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 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.