Gilead wins a blockbuster consolation prize with EC, Japanese approvals for filgotinib — but that barely softens the blow of the FDA's CRL
The FDA’s recent slapdown of Gilead’s rheumatoid arthritis JAK filgotinib didn’t even slightly delay its arrival in 2 big world markets. The EC stamped its marketing authorization on the blockbuster candidate at the end of the week, following the news that Japanese regulators had offered its green light a bit earlier.
The FDA’s decision to hold up the drug on frets over the risk and rewards of the drug, preferring to wait for more safety data to roll in, spurred a major rethink at Gilead, with the suggestion that CEO Dan O’Day might just decide to forego the whole affair if the US throws up a roadblock so high it would block off the billions in sales he was hoping for.
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