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GSK's Nucala For COPD Faces Questions On Efficacy Results, Missing Data

 
• By Derrick Gingery

US FDA advisory committee will consider impact of trial design, given that GSK did not collect asthma histories and chronic oral corticosteroid use information from its COPD study participants.

COPD awareness frame poster with lungs filled with air bubbles on red background. Chronic obstructive pulmonary disease symbol. Medical template for clinics and centers. Vector illustration.

The US FDA is questioning the efficacy data and other information supporting the addition of a potentially novel COPD indication to GlaxoSmithKline PLC's Nucala (mepolizumab) in advance of a July 25 advisory committee review of the supplemental application.

Nucala is seeking a claim as an add-on treatment to inhaled corticosteroid-based maintenance treatment for reduction of exacerbations in patients with chronic obstructive pulmonary disease guided by blood eosinophil counts. The anti-interleukin-5 monoclonal antibody already approved for treatment of severe asthma in patients 12 years and older with the eosinophilic phenotype

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Maybe In May: US FDA Calls Coming On Moderna Next-Gen COVID-19 Vaccine, AbbVie’s Big ADC Bet

 
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