GSK

GlaxoSmithKline plc  received approval from the US Food and Drug Administration (FDA) for its Biologics License Application (BLA) for Nucala® (mepolizumab) as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Nucala is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.

GSK and Merck, known as MSD outside the US and Canada, announced the initiation of a phase I clinical trial designed to evaluate GSK’s investigational immunotherapy GSK3174998 as monotherapy and  in combination with Merck’s anti-PD-1 therapy, Keytruda® (pembrolizumab) in patients with locally advanced, recurrent or metastatic solid tumour(s) that have progressed after standard treatment.

GSK announced that stepwise trial design of its losmapimod phase III study, LATITUDE-TIMI 60, an interim review of data from part A of the study (an initial cohort of 3,503 patients) did not indicate efficacy against the primary endpoint and did not support investment in the larger part B of the study as currently designed.