Tags : Asthma

Sanofi Reports Results of Dupixent (dupilumab) in P-III LIBERTY ASTHMA

Shots: The P-III LIBERTY ASTHMA VOYAGE study involves assessing of Dupixent (SC, 100/200mg, q2w ) + SOC maintenance therapy of medium-dose ICS with a second controller medication/ high-dose ICS with/out second controller medication vs PBO in 408 children 6 to <12 years old with uncontrolled moderate-severe asthma Results: Patients with baseline blood EOS ≥300 cells/μl […]Read More

GSK and Innoviva’s Trelegy Ellipta (FF/UMEC/VI) Receive the US FDA’s

Shots: The approval is based on an sNDA which includes data from CAPTAIN study assessing Trelegy (qd, 100/62.5/25, 200/62.5/25, 100/31.25/25, and 200/31.25/25 mcg) vs FF/VI (100/25 and 200/25 mcg) to patients whose asthma was inadequately controlled despite treatment with ICS/LABA Results: Trelegy (qd, easy-to-use inhaler) demonstrated improvements in lung function, presented at ERS Congress. The […]Read More

Sanofi Reports Results of Dupixent (dupilumab) in P-III LIBERTY ASTHMA

Shots: The P-III OLE study involves assessing of Dupixent (300mg) + SOC in 2,282 adults/ adolescents with mod.-to-sev. asthma prior participated in a controlled Dupixent clinical trial, including the pivotal P-IIb DRI (24wks.) and P-III QUEST (52wks.) trials in patients with mod.-to-sev. asthma and the P-III VENTURE (24wks.) trial in patients with severe OCS-dependent asthma […]Read More

Novartis’ Enerzair Breezhaler Receives the EC’s Approval as a Maintenance

Shots: The approval is based on P-III IRIDIUM study assessing Enerzair Breezhaler (qd) vs Atectura Breezhaler (QMF149; IND/MF) in 3092 patients in the ratio (1:1:1:1) whose asthma is uncontrolled with LABA/ICS SOC treatment which resulted in improvement of ACQ-7 score @26wks., reductions in asthma exacerbation rates were observed in moderate-to-severe and safety profile was consistent […]Read More

Boehringer Ingelheim Reports Real-World Data for Spiriva Respimat (tiotropium bromide)

Shots: The real-world data involves assessing of Spiriva Respima Inhalation Spray 1.25mcg + combination inhaled corticosteroid and long-acting beta2-agonist (ICS+LABA) vs increased dose of ICS+LABA or continuing high dose of ICS+LABA in patients with asthma The study resulted in 73% lower exacerbation rates and 76% lower hospitalization rates in comparison to increased dose of ICS+LABA […]Read More

GSK Reports Results of Trelegy Ellipta in P-III CAPTAIN Study

Shots: The P-III CAPTAIN study involves assessing of Trelegy Ellipta (FF/UMEC/VI) (100/31.25/25, 100/62.5/25, 200/31.25/25 and 200/62.5/25 mcg) vs Relvar/Breo Ellipta (FF/VI) (100/25 and 200/25 mcg) in 2,436 patients with uncontrolled asthma prior treated with ICS/LABA across 15 countries The P-III CAPTAIN study results: met its 1EPs; @24wks. 100/62.5/25mcg vs 200/62.5/25mcg, improvement in lung function & […]Read More