FDA re­jects Eiger's emer­gency use re­quest for re­pur­posed Covid-19 treat­ment

Eiger Bio­Phar­ma­ceu­ti­cals is no longer plan­ning to sub­mit an emer­gency use ap­pli­ca­tion to the FDA.

The Pa­lo Al­to, CA-based biotech had hoped to re­pur­pose its he­pati­tis D treat­ment, pegin­ter­fer­on lamb­da, for mild-to-mod­er­ate Covid-19 — sub­mit­ting a re­quest to the FDA for a pre-EUA meet­ing back in Sep­tem­ber with da­ta from a Phase III plat­form tri­al in hand.

How­ev­er, that meet­ing was re­ject­ed by fed­er­al reg­u­la­tors be­cause of “con­cerns about the con­duct of the TO­GETH­ER study,” per an Eiger state­ment.

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