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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• Publié par: mundipharma
• Nombre de lectures: 23
• Langue: English

Extrait

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