Mundipharma today announced the positive European Commission (EC) decision for flutiform® (fluticasone propionate/formoterol fumarate), a new combination therapy for the maintenance treatment of asthma, in Europe.
This decision is binding on all 21 Member States involved in the decentralised procedure (DCP).
The first national approvals of flutiform are expected across a number of countries by the end of 2012. Timings of these will be dependent on negotiations with the national regulatory and, where relevant, reimbursement authorities.
The combination of fluticasone propionate (fluticasone), an inhaled corticosteroid (ICS), and formoterol fumarate (formoterol), a long-acting â2-agonist (LABA) 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 (50/5µg and 125/5µg strengths) and in adults (250/10µg strength) whose symptoms are not adequately controlled on an ICS and an as-required inhaled short-acting â2-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.
*Please note flutiform® is currently not available for use within Europe