FDA calls for more data before approving Nucala sBLA

The US FDA has issued a complete response letter (CRL) regarding the supplementary Biologics License (sBLA) 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 drug’s maker, GlaxoSmithKline (LSE: GSK), said on Friday that the CRL calls more clinical data to support an approval. GSK says it will work closely with the FDA to determine the appropriate next steps for the (sBLA).

The decision is not surprising given that, in July this year, the FDA’s Pulmonary Allergy Drugs Advisory Committee gave a negative, non-binding opinion on the approval of the drug in the COPD indication.