Tags : mepolizumab

GSK Reports Results of Nucala (mepolizumab) in P-III Study for

Shots: The P-III study involve assessing Nucala (300mg, q4w, SC) vs PBO in 108 adolescent and adult patients with severe HES for 32wks. The P-III study results: met its 1EPs i.e, reduction in flares with 50% fewer patients experiencing HES flare (56% vs 28%). 2EPs: 66% lower risk of first HES flare; 66% reduction in […]Read More

GSK Reports Results of Nucala (mepolizumab) in REALITI-A Study for

Shots: The REALITI-A study involves assessing of Nucala (100mg, SC) in 368 patients with severe eosinophilic asthma, being conducted in a routine care setting, compared to the prior 12mos. The REALITI-A study results: annual reduction rate in exacerbations (69%); reduction in exacerbations requiring hospitalization/emergency room visits (77%); reduction in m-oral corticosteroid (OCS) dose 10 mg/day […]Read More

GSK’s Nucala (mepolizumab) Receives the US FDA’s Approval as First

Shots: The US FDA’s approval follows the open-label study evaluating PK/PD and long-term safety of Nucala (40mg, SC) in children with severe eosinophilic asthma aged 6 to 11yrs. The approval is also supported by results of well-controlled studies assessing Nucala in adults and adolescents The 52wks. long term study of Nucala in pediatric patients aged […]Read More

GSK’s Nucala (mepolizumab) Receives European Commission Approval for Self-Administration in

Shots: The Nucala has received EMA’s marketing authorization for its new methods of administration i.e, a pre-filled pen and a pre-filled safety syringe with their anticipated launch in Europe in Aug’2019 The MAA is based on two P-IIIa studies (NCT03099096 & NCT03021304) which demonstrated that patients were able to administer Nucala with the pre-filled pen […]Read More

GSK’s Nucala (mepolizumab) Receives FDA’s Approval for its Two New

Shots: The approval is based on P-IIIa studies (NCT03099096 & NCT03021304) assessing Nucala in-clinic and at home for patients with severe eosinophilic asthma (SEA). Additionally, a study (NCT03014674) evaluated Nucala’s PK and PD via auto-injector & pre-filled syringe was comparable with approved lyophilised formulation The study resulted in 89-95% and 100% successful self-administered treatment with […]Read More