Ab­b­Vie’s first post-merg­er Al­ler­gan drug pitch strikes out with the FDA as reg­u­la­tors turn thumbs down on Lu­cen­tis chal­lenger

Al­ler­gan has re­ceived its first FDA de­ci­sion since of­fi­cial­ly be­com­ing a part of Ab­b­Vie. And it’s bad news.

Reg­u­la­tors have spurned abic­i­par, the neo­vas­cu­lar age-re­lat­ed mac­u­lar de­gen­er­a­tion (wet AMD) drug that Al­ler­gan chief Brent Saun­ders had tout­ed as one of four “ex­pect­ed” ap­provals just be­fore an­nounc­ing the $63 bil­lion sale.

The com­pa­ny said the com­plete re­sponse let­ter took is­sue with “the rate of in­traoc­u­lar in­flam­ma­tion” ob­served af­ter ad­min­is­tra­tion of the an­ti-VEGF in­jec­tion (2mg/0.05 mL) — which trans­lates to an un­fa­vor­able ben­e­fit-risk ra­tio.

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