Dan O'Day, Gilead CEO (AP Images)

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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