Innovent/Lilly PD-1 Rejected by US FDA Panel; Lilly Says Price 40% Below Competition

As predicted, a US FDA oncology advisory panel rejected the NDA submitted by Innovent and Lilly for their partnered anti-PD-1 antibody. Before the panel met, Lilly tried to influence the panel to approve the drug, sintilimab (Tyvyt), by announcing it would offer the drug at a wholesale price 40% lower than the US competition. The last-minute strategy didn't work: the panel voted 14-1 against approval. Yesterday, it seemed the main problem was the Phase III trial, which included only people with China genomes. But there were other issues as well. More details....

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