FDA’s in­sid­er re­view rais­es se­ri­ous safe­ty is­sues as Eli Lil­ly’s quick come­back shot for baric­i­tinib heads for ex­pert show­down

Eli Lil­ly $LLY has got some ex­plain­ing to do. 

And un­like the FDA, which abrupt­ly re­versed course on their re­jec­tion of Lil­ly’s baric­i­tinib for rheuma­toid arthri­tis with­out ever ful­ly out­lin­ing the rea­sons for the about-face, there’s no get­ting around the chal­lenge for the phar­ma gi­ant.

It’s clear from the agency’s in­ter­nal re­view, which in­cludes con­flict­ing con­clu­sions from dif­fer­ent FDA of­fi­cials on the safe­ty and ben­e­fit of the drug, that the agency had a big prob­lem with ev­i­dence that Lil­ly’s drug trig­gered throm­bo­sis in pa­tients. Like any pow­er­ful im­mune sup­pres­sant, the Lil­ly drug was linked with a va­ri­ety of re­lat­ed symp­toms, but throm­bo­sis — dan­ger­ous blood clot­ting — is not com­mon to the class.

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