Pfizer/BI Spiriva Dyspnea Claim Rejected Due To Unvalidated Endpoint
This article was originally published in Pharmaceutical Approvals Monthly
Pfizer/BI Spiriva dyspnea indication rejected due to non-validated primary endpoint, poor protocol, FDA review documents state. Supporting studies for the indication showed a statistically higher response rate than placebo, but not compared to active comparator salmeterol. While FDA indicated that a dyspnea endpoint would need to be pre-specified for pursuit of the COPD-associated indication, the sponsors opted to amend the protocols after the studies were completed
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