FDA kicks Re­gen­eron’s lat­est Eylea ap­pli­ca­tion to the curb, but they’re not sweat­ing it

Re­gen­eron $REGN says the FDA has re­ject­ed their ap­pli­ca­tion to sell a pre-filled sy­ringe with Eylea, de­lay­ing a sup­ple­men­tal add-on that the biotech wants to safe­guard its big block­buster fran­chise from a ri­val. But the com­pa­ny was quick to spell out the rea­sons for the CRL, as­sert­ing that it can get things in line for reg­u­la­tors by ear­ly 2019.

Their state­ment:

The CRL re­quest­ed ad­di­tion­al in­for­ma­tion re­gard­ing man­u­fac­tur­ing and sup­ply process­es and the com­ple­tion of a us­abil­i­ty study eval­u­at­ing a sin­gle in­jec­tion of the Eylea pre-filled sy­ringe in ap­prox­i­mate­ly 30 pa­tients. Re­gen­eron ex­pects to com­pile all the re­quest­ed in­for­ma­tion and re­sub­mit the PAS in ear­ly 2019 and con­tin­ues to ex­pect a 2019 launch of the Eylea pre-filled sy­ringe.

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