FDA needs more data to support Nucala for COPD

GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) received a complete response letter from FDA to an sBLA for Nucala mepolizumab to treat chronic obstructive pulmonary disease. According to the pharma, the agency said more clinical data are required to support approval.

In July, FDA’s Pulmonary-Allergy Drugs Advisory Committee voted against Nucala’s approval in COPD based on efficacy data and the drug's benefit-risk profile (see “Committee Votes No on GSK’s Nucala for COPD”)...