Positive European Commission Decision on flutiform® (fluticasone propionate/formoterol fumarate), a New Combination Therapy for Asthma

Positive European Commission Decision on flutiform® (fluticasone propionate/formoterol fumarate), a New Combination Therapy for Asthma

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Positive European Commission Decision on flutiform® (fluticasone propionate/formoterol fumarate), a New Combination Therapy for Asthma PR Newswire CAMBRIDGE, England, July 3, 2012 CAMBRIDGE, England, July 3, 2012 /PRNewswire/ -- First national approvals expected by the end of 2012 Mundipharma today announced the positive European Commission (EC) decision for f l u t i f o r m ® (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 decentralised procedure (DCP) and the first national approvals of f l u t i f o r m 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 β -2 agonist (LABA) therapy is delivered via a single aerosol inhaler for the first time. f l u t i f o r m 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 β -agonist (SABA), and in those patients who are2 [1]already receiving treatment with both an ICS and LABA.

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Positive European Commission Decision on
flutiform® (fluticasone propionate/formoterol
fumarate), a New Combination Therapy for
Asthma
PR Newswire
CAMBRIDGE, England, July 3, 2012
CAMBRIDGE, England
,
July 3, 2012
/PRNewswire/ --
First national approvals expected by the end of 2012
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 Concerned Member States involved in the
decentralised procedure (DCP) and 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 β
2
-
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 (50/5µg 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 β
2
-agonist (SABA), and in those patients who are
already receiving treatment with both an ICS and LABA.
[1]
"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
Clinical evidence behind
flutiform
®
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
[4]
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
[4]
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 μg b.i.d.) compared to the
fluticasone/salmeterol
combination (100/50 or 250/50 μg b.i.d.) was shown over a 12-week study period (HR
1.64)
[3]
has a safety and tolerability profile similar to that of its individual components
administered concurrently via separate inhalers
[4]
About Mundipharma
Mundipharma International provides fully integrated support across multiple
disciplines for a network of independent pharmaceutical companies across
Europe
. The Mundipharma independent associated companies have become
leaders in pain management, and are building a growing presence in the
oncology, rheumatoid arthritis and respiratory markets. Through innovation
and acquisition, the Mundipharma mission is to deliver cutting-edge treatment
solutions that meet the pressing needs of healthcare professionals and
patients. For more information: http://www.mundipharma.com
® denotes a registered trade mark
References
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