FDA ad­vi­sors unan­i­mous­ly re­ject Intar­ci­a's em­bat­tled type 2 di­a­betes treat­ment

I2o Ther­a­peu­tics CEO Kurt Graves set out on Thurs­day to make a case to a pan­el of the FDA’s ex­pert ad­vi­sors that the ben­e­fits of his com­pa­ny’s twice-re­ject­ed im­plant to treat type 2 di­a­betes out­weigh its risks — but the com­mit­tee wasn’t con­vinced.

The FDA’s En­docrino­log­ic and Meta­bol­ic Drugs Ad­vi­so­ry Com­mit­tee con­clud­ed in a 19-0 vote that the ben­e­fits of Intar­cia’s IT­CA 650 do not out­weigh the risks as­so­ci­at­ed with the drug-de­vice com­bi­na­tion prod­uct. The ad­vi­sors large­ly con­curred with the FDA’s ex­ist­ing safe­ty con­cerns about the treat­ment, which in­clude the risk of acute kid­ney in­jury, ma­jor ad­verse car­dio­vas­cu­lar events and oth­er se­ri­ous ad­verse events.

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