Tags : Nucala

Regulatory

GSK’s Nucala Receives Health Canada’s Approval for Severe Eosinophilic Asthma

Shots: Nucala (mepolizumab) has received Health Canada’s approval as an add-on maintenance therapy for adolescents & children aged ≥6yrs. with SEA  The extension of NUCALA’s indication for adolescents and children aged ≥6yrs. allow the company to bring the therapy to patients and their families with limited treatment options Nucala is the first IL5 biologic to […]Read More

Biotech

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

Regulatory

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

Biotech

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

Pharma

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