A regulatory review that took much longer than usual and ended in a restricted indication that leaves little scope for the product in question to carve out a meaningful place in the relevant treatment pathway. Reviewers suggesting that a different comparator might have achieved better results and that using the comparator in question may have distorted the results in favor of the product under review. Clinical trials involving 572 individuals recruited in 275 sites across 33 countries.
Piqray: What EU Regulators Saw And What They Wanted
The European public assessment report for Novartis's advanced breast cancer therapy, Piqray (alpelisib), includes some interesting insights into what EU regulators are looking for in drug company clinical trials.
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