US FDA Rejection Stings Nucala In COPD; New Study May Be Needed
Mepolizumab would be first drug for chronic obstructive pulmonary disorder to use eosinophil count as a biomarker, but FDA’s complete response letter says more clinical data are needed.
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By combining its expertise in respiratory and vaccines, the UK drugs giant could have a potential blockbuster for chronic obstructive pulmonary disease, which is expected to become the third leading cause of death worldwide by the end of the decade.
AstraZeneca's R&D leader admits mistakes in earlier failed Phase III trials. A new study will target the high eosinophil sub-group.
Unclear data on monoclonal antibody's efficacy caused many members of Pulmonary-Allergy Drugs Advisory Committee to vote against recommending approval.