Rac­ing No­var­tis on Eylea ri­val, the FDA trips up Re­gen­eron at the fin­ish line

An ag­gres­sive Re­gen­eron $REGN has run in­to a road­block in its quest to get out ahead of a po­ten­tial Eylea ri­val from No­var­tis.

The big biotech, not known for ca­su­al­ly ced­ing mar­ket ter­ri­to­ry to any com­peti­tor, says its sup­ple­men­tal BLA for its once-every-12 week dose of Eylea for wet, age-re­lat­ed mac­u­lar de­gen­er­a­tion has been re­ject­ed by the FDA.

Fac­ing an Au­gust 11 PDU­FA dead­line, says Re­gen­eron, the FDA kicked out the ap­pli­ca­tion “due to on­go­ing la­bel­ing dis­cus­sions” — and that could in­di­cate a big ad­van­tage for its ri­vals at No­var­tis.

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