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05.06.2020 07:14:49

Press Release: Novartis Phase IIIb ARGON study meets primary endpoint in a comparison of Enerzair(R) Breezhaler(R) (QVM149) versus a free combination of two ...

-- Once-daily Enerzair(R) Breezhaler(R) (QVM149; IND/GLY/MF) met primary

endpoint, demonstrating non-inferiority to a free combination of

twice-daily Sal/Flu plus once-daily tiotropium (Tio), in improving

quality of life in people with uncontrolled asthma1.

-- Among secondary analyses, improvements in lung function, asthma control,

health status, and a reduction in moderate exacerbations were observed

with once-daily high-dose IND/GLY/MF compared to a free combination of

high-dose Sal/Flu plus Tio1.

-- IND/GLY/MF recently received a positive opinion from the European

Medicines Agency's Committee for Medicinal Products for Human Use (CHMP)

and is currently under regulatory review in multiple countries.

-- If approved, once-daily IND/GLY/MF will be the first LABA/LAMA/ICS

fixed-dose combination for patients whose asthma is uncontrolled with

LABA/ICS treatment and could provide an effective and convenient

alternative to the current standard-of-care regimen.

Basel, June 5, 2020 -- Novartis today announced that full results from

the Phase IIIb ARGON study were published online in Respiratory

Medicine. These results show that once-daily treatment with single

inhaler, high- and medium-dose Enerzair(R) Breezhaler(R) (QVM149;

indacaterol acetate, glycopyrronium bromide and mometasone furoate

[IND/GLY/MF]) demonstrated non-inferiority to a free combination of

twice-daily, high-dose salmeterol xinafoate/fluticasone propionate

(Sal/Flu) plus once-daily tiotropium (Tio), delivered in two different

devices, in improving quality of life in people with uncontrolled

asthma(1). Among secondary analyses, improvements in lung function,

asthma control, health status, and reductions in moderate exacerbations

were observed with high-dose once-daily IND/GLY/MF compared to high-dose

Sal/Flu plus Tio(1).

"Today, over 45% of patients at GINA Steps 4 and 5 remain uncontrolled,

despite current therapy, demonstrating the need for additional treatment

options in this patient population," said Assistant Professor Christian

Gessner, Head of POIS Leipzig Study Centre and Guest Doctor at

Universität Leipzig. "The ARGON study shows that once-daily

IND/GLY/MF improves quality of life and, if approved, could provide an

effective and convenient treatment for patients whose asthma is

uncontrolled with LABA/ICS treatment."

The primary endpoint of the study was met, with both high- and medium-

doses of IND/GLY/MF demonstrating non-inferiority in change from

baseline in Asthma Quality of Life Questionnaire (AQLQ) score (high:

0.073; medium: -0.038; both p<0.001)(1).

"Novartis is reimagining respiratory medicine by developing innovative,

patient-focused medicines such as IND/GLY/MF that address areas of

significant unmet clinical need and improve symptom control and quality

of life for people with asthma," said Dominic Brittain, Respiratory

Global Program Head, Novartis Pharmaceuticals. "The ARGON study results

show the potential benefits of this once-daily, single inhaler,

LABA/LAMA/ICS treatment option in patients with uncontrolled asthma.

These data build on the clinically meaningful improvements in lung

function and reduction of exacerbations observed for high-dose

IND/GLY/MF in the IRIDIUM study."

In secondary analyses, improvements in asthma control (as measured by

Asthma Control Questionnaire; ACQ-7 score [-0.124; p=0.004]) and lung

function (as measured by trough FEV(1) [96 mL; p<0.001]) were seen with

high-dose IND/GLY/MF compared with high-dose Sal/Flu plus Tio(1). In

additional exploratory analyses, improvements in health status (as

measured by St. George's Respiratory Questionnaire; SGRQ [-2.00;

p=0.04]), and peak expiratory flow (morning [9.56 L/min; p=0.005],

evening [9.15 L/min; p=0.006]) were seen with high-dose IND/GLY/MF

compared with high-dose Sal/Flu plus Tio(1). A greater reduction in the

rate of moderate exacerbations (43%; p=0.04) was seen with high-dose

IND/GLY/MF versus high-dose Sal/Flu plus Tio; the rate of exacerbations

across all severities was comparable between the two treatment groups(1)

. Comparable efficacy in these endpoints was seen with medium-dose

IND/GLY/MF versus high-dose Sal/Flu plus Tio, but at a corresponding

lower steroid dose(1). Adverse events were generally comparable across

treatments(1).

The ARGON study assessed IND/GLY/MF, a once-daily, fixed-dose

combination of a long-acting beta(2) -agonist (LABA), a long-acting

muscarinic antagonist (LAMA) and an inhaled corticosteroid (ICS) in

high- (150/50/160 ug) and medium- (150/50/80 ug) doses, delivered via

the Breezhaler(R), compared with a free combination of twice-daily

high-dose Sal/Flu (50/500g) plus once-daily Tio (5 g) in

patients with asthma not adequately controlled on current inhaled

therapies, over 24 weeks of active treatment(1).

To date, high-dose IND/GLY/MF has received a positive opinion from the

European Medicines Agency's Committee for Medicinal Products for Human

Use (CHMP); this submission was supported by the IRIDIUM study(1,2).

The positive opinion for Enerzair(R) Breezhaler(R) also covered a

digital companion with app and sensor that provide inhalation

confirmation, medication reminders and access to objective data to

better support therapeutic decisions. Further regulatory reviews are

currently underway in multiple countries, including Switzerland and

Japan.

In keeping with the Novartis commitment to reduce the environmental

impact of our asthma combinations, IND/GLY/MF will be available in the

Breezhaler(R) device which is hydrofluoroalkane/chlorofluorocarbon

(HFA/CFC)-free.

About Uncontrolled Asthma

Asthma affects an estimated 358 million people worldwide and can cause a

significant personal, health and financial burden when not adequately

controlled(3,4). Despite current therapy, over 40% of patients with

asthma at Global Initiative for Asthma (GINA) Step 3, and over 45% at

GINA Steps 4 and 5 remain uncontrolled(5,6). Patients with uncontrolled

asthma may downplay or underestimate the severity of their disease and

are at a higher risk of exacerbation, hospitalization or death(7,8,9).

Barriers, such as treatment mismatch, safety issues with an oral

corticosteroid and ineligibility for biologics, have created an unmet

medical need in asthma(10,11).

About Enerzair(R) Breezhaler(R) in the EU

The CHMP adopted a positive opinion recommending the approval of

high-dose Enerzair(R) Breezhaler(R) (QVM149; IND/GLY/MF) 150/50/160

g once-daily as a maintenance treatment of asthma in adult patients

not adequately controlled with a maintenance combination of a

long--acting beta(2) --agonist (LABA) and a high dose of an inhaled

corticosteroid (ICS) who experienced one or more asthma exacerbations in

the previous year(12). This formulation combines the bronchodilation of

indacaterol acetate (a LABA) and the antimuscarinic effects of

glycopyrronium bromide (a LAMA) with mometasone furoate (ICS) in a

precise once-daily formulation, delivered via the dose-confirming

Breezhaler(R) device. Glycopyrronium bromide certain use and formulation

intellectual property were exclusively licensed to Novartis in April

2005 by Sosei Heptares and Vectura. Mometasone furoate is exclusively

licensed to Novartis from a subsidiary of Merck & Co., Inc, Kenilworth,

NJ, USA, for use in IND/GLY/MF (worldwide excluding the US).

IND/GLY/MF will be administered via the dose-confirming Breezhaler(R)

device, which enables once-daily inhalation using a single inhaler. If

approved, IND/GLY/MF will be the first asthma treatment in the EU that

can be prescribed together with a digital companion; the Propeller

Health app and a sensor custom-built for the Breezhaler(R) device. The

digital companion will provide patients with inhalation confirmation,

medication reminders and access to objective data that can be shared

with their physician in order to help them make better therapeutic

decisions. The sensor for the Breezhaler(R) device was developed by

Propeller Health and is a CE marked Medical Device, designed and

licensed to Novartis exclusively for use with the Breezhaler(R) inhaler

worldwide. The sensor includes a microchip, a microphone, Bluetooth

capabilities, an antenna and a battery. The sensor does not alter the

drug delivery characteristics of the Breezhaler(R) inhaler itself but

produces a recording of each administered dose. Based on the patient's

recorded medication usage, personalized content is presented within the

app to help the patient better self-manage their asthma.

About the PLATINUM Clinical Development Program

The PLATINUM program, containing over 7,500 patients worldwide, is the

Novartis Phase III/IIIb clinical development program supporting the

development of IND/GLY/MF and IND/MF. It includes four studies: the

QUARTZ study, which compared a low-dose of IND/MF with MF alone; the

PALLADIUM study, which compared IND/MF with MF and salmeterol

xinafoate/fluticasone propionate (Sal/Flu); the IRIDIUM study, which

compared IND/GLY/MF with IND/MF and Sal/Flu; and the ARGON study, which

compared IND/GLY/MF with a free combination of Sal/Flu plus tiotropium

(Tio).

About the ARGON study(1)

ARGON (NCT03158311) is a Phase IIIb, multicenter, randomized, 24-week,

parallel-group, non-inferiority, open-label (blinded for the two

IND/GLY/MF tested doses), active-controlled study comparing the efficacy

and safety of IND/GLY/MF with a free combination of salmeterol

xinafoate/fluticasone propionate (Sal/Flu) plus tiotropium (Tio) in

patients with uncontrolled asthma.

The purpose of this trial was to demonstrate that the efficacy of two

doses of the fixed-dose combination product IND/GLY/MF (high: 150/50/160

g and medium: 150/50/80 g) is non-inferior to the efficacy of

the free combination of Sal/Flu (50/500 g) plus Tio (5 g) in

patients with uncontrolled asthma.

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June 05, 2020 01:15 ET (05:15 GMT)