FDA gives complete response for Nucala in COPD.- GSK.

GlaxoSmithKline has received a complete response letter (CRL) from the US FDA regarding its application for Nucala (mepolizumab) as an add-on treatment to inhaled corticosteroid-based maintenance treatment for the reduction of exacerbations in patients with chronic obstructive pulmonary disease (COPD), guided by blood eosinophil counts. The CRL states that more clinical data are required to support an approval. GSK will work closely with the FDA to determine the appropriate next steps for the supplementary biologics licence application (sBLA).

Comment: In august 2018, the FDA committee voted on the basis of data presented that the risk-benefit profile was not adequate to support approval of Nucala for COPD (3 for, 16 against). The committee also voted that there was not substantial evidence of the efficacy (3 for, 16 against) but there was adequate evidence of the safety (17 for, 2 against) of mepolizumab in this population and the committee suggested further data to characterise the patient population that would be most likely to benefit from this targeted biologic therapy.