GSK announces positive results from phase III severe asthma trials …
May 21, 2024 · GSK plc (LSE/NYSE: GSK) today announced positive headline results from the phase III clinical trials SWIFT-1 and SWIFT-2, which assessed the efficacy and safety of depemokimab versus placebo in adults and adolescents with severe asthma with type 2 inflammation characterised by blood eosinophil count. 1,2 Both SWIFT-1 and SWIFT-2 …
Depemokimab accepted for review by the European Medicines Agency ... - GSK
3 days ago · Depemokimab, a monoclonal antibody that targets interleukin-5 (IL-5), is the first ultra-long-acting biologic to be evaluated in phase III trials and be accepted for regulatory review for use in these conditions. 1 Depemokimab's extended half-life, high-binding affinity and potency, support six month (26 week) dosing regimens based on results ...
GSK announces positive phase III results from ANCHOR trials for ...
Oct 14, 2024 · Depemokimab’s extended half-life, high potency and high binding affinity for IL-5 means it has the potential to provide sustained inhibition of broad inflammatory functions with dosing once every six-months. The phase III programme includes evaluation of depemokimab in other IL-5 mediated diseases.
GSK : Depemokimab accepted for review by the European …
2 days ago · ANCHOR-1 and -2 showed depemokimab reduced nasal polyp size and obstruction compared to placebo. GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency has accepted for review the Marketing Authorisation Application for the use of depemokimab in two indications.
Phase III Trials Show Depemokimab Reduces Severe Asthma …
Jun 12, 2024 · In addition to SWIFT-1 and SWIFT-2, GSK is conducting the NIMBLE study, which evaluates the efficacy and safety of depemokimab in patients transitioning from other IL-5-targeting therapies, such as mepolizumab or benralizumab. An open-label extension study, AGILE, is also underway to further assess long-term outcomes.
Twice-Yearly Depemokimab in Severe Asthma with an …
Sep 9, 2024 · Depemokimab is an ultra-long-acting biologic therapy with enhanced binding affinity for interleukin-5 that may enable effective 6-month dosing intervals.
Depemokimab applications accepted for review in China and …
2 days ago · Depemokimab, a monoclonal antibody that targets interleukin-5 (IL-5), is the first ultra-long-acting biologic to be evaluated in phase III trials and be accepted for regulatory review for use in these conditions. 1 Depemokimab's extended half-life, high-binding affinity and potency, support six month (26 week) dosing regimens based on results ...
More on GSK’s Depemokimab Filings - Yahoo Finance
1 day ago · GSK’s regulatory filings are supported by positive data from two late-stage programs – SWIFT and ANCHOR. While the SWIFT studies evaluated depemokimab in asthma indications, the ANCHOR studies ...
Stopwatch starts on reviews of GSK's long-acting asthma drug
2 days ago · Depemokimab is a follow-up to GSK's Nucala (mepolizumab), a once-monthly IL-5 inhibitor approved for severe asthma, CRSwNP, eosinophilic granulomatosis with polyangiitis (EGPA), and ...
GSK to Approach FDA With Positive Phase III Data For Long
Sep 9, 2024 · GSK’s twice-yearly depemokimab reduced asthma attacks by half and cut clinic visits by nearly three-quarters, positioning it for an estimated $4 billion in peak sales if approved.