A Picture is Worth a Thousand Words
This article was originally published in RPM Report
One FDA advisory committee urges a sponsor to get graphic in its REMS for a weight loss drug. Another committee rejects an expanded label after FDA shows a picture of the risk in its presentation.
You may also be interested in...
Vivus’ second trip to an advisory panel was a much happier one, with the company’s weight loss therapy garnering an overwhelming “yes” vote on approvability. The key change? A Risk Evaluation & Mitigation Strategy that will be precedent setting if approved—and that demonstrates the power of REMS even if FDA moves in a different direction with this application.
Measurement of a downstream endpoint, such as delay in skeletal-related events, could have been better than radiographic scans to assess efficacy of denosumab in delaying bone metastases in high-risk castration-resistant prostate cancer patients, several ODAC members contend.
Past support for so-called ‘march in’ rights is a red flag for biopharma innovators, but after two days of confirmation hearings, industry can be somewhat reassured.