さんきゅ 0111山師さん@トレード中2020/06/05(金) 20:17:55.93ID:I8qGLMZc0 M1だめだろう 0112山師さん@トレード中2020/06/05(金) 20:32:49.04ID:YR4gHHS70 バカルサーw 0113山師さん@トレード中2020/06/05(金) 20:52:26.09ID:I0BbCrMW0 これはあっぱれ 0114山師さん@トレード中2020/06/05(金) 21:36:52.08ID:GsUmWmnB0>>111 下がって欲しいのねwww 0115山師さん@トレード中2020/06/05(金) 22:08:47.00ID:t0Krrr7AM ハイカラさんが通る 0116山師さん@トレード中2020/06/05(金) 23:33:09.25ID:aoKQhqkJM うんこしてるときにたまたま板見て他おかげで買えたわ 家宝にします 0117山師さん@トレード中2020/06/06(土) 05:30:59.54ID:budG0ywf0 ※Novartis: "Novartis Phase IIIb ARGON Study Meets Primary Endpoint in a Comparison of Enerzair Breezhaler (QVM149) Versus a Free Combination of Two Existing Inhaled Treatments in Uncontrolled Asthma". (6/5)
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 Breezhaler (QVM149; [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. 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.
“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.”
“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.” 0118山師さん@トレード中2020/06/06(土) 05:31:23.73ID:budG0ywf0 The ARGON study assessed IND/GLY/MF, a once-daily, fixed-dose combination of a LABA, a LAMA and an ICS in high- (150/50/160 µg) and medium- (150/50/80 µg) doses, delivered via the Breezhaler, compared with a free combination of twice-daily high-dose Sal/Flu (50/500μg) plus once-daily Tio (5 μg) in patients with asthma not adequately controlled on current inhaled therapies, over 24 weeks of active treatment. 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. The positive opinion for Enerzair Breezhaler 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 device which is hydrofluoroalkane/chlorofluorocarbon (HFA/CFC)-free.
About Enerzair Breezhaler in the EU: IND/GLY/MF will be administered via the dose-confirming Breezhaler 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 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® device was developed by Propeller Health and is a CE marked Medical Device, designed and licensed to Novartis exclusively for use with the Breezhaler 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 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. 0119山師さん@トレード中2020/06/06(土) 05:32:04.84ID:budG0ywf0 ※Sosei Heptares:「コントロール不良な喘息患者を対象とした Enerzair Breezhaler(QVM149)の第Vb 相臨床試験(ARGON 試験)において主要評価項目を達成」(6/5)