Tags : Severe Eosinophilic Asthma

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

AstraZeneca Reports Results of Fasenra in BORA P-III Extension trial

Shots: The BORA P-III trial involves assessing of Fasenra (benralizumab) enrolling patients in ratio (1:1) who have completed one of the two SIROCCO or CALIMA P-III trials, administering Fasenra 30 mg SC q4w or q8w BORA results (N= 1926): improvement in efficacy outcomes; overall annual asthma exacerbation rate (eosinophil counts of 300 cells per μL) […]Read More

GSK’s Nucala Proves to be Superior than AZ’s Fasenra and

Shots: The comparison study led to assessing of Nucala (mepolizumab), Fasenra (benralizumab), Cinqair (reslizumab) in patients aged ≥12 yrs with similar blood eosinophil counts for the treatment of severe eosinophilic asthma Results: Nacula 100mg SC reduces clinically significant exacerbations (34% to 45% vs Fasenra 30mg) and (45% vs Cinqair 3mg/kg) in ≥400 cells/μL based on […]Read More