Ac­er, Re­lief win FDA ap­proval for rare meta­bol­ic dis­ease af­ter clear­ing in­spec­tion hur­dles

Ac­er Ther­a­peu­tics and its Swiss part­ner Re­lief Ther­a­peu­tics cel­e­brat­ed an FDA ap­proval on Tues­day for Ol­pru­va, an oral drug for urea cy­cle dis­or­ders (UCDs).

The news comes rough­ly six months af­ter reg­u­la­tors re­ject­ed Ol­pru­va, al­so known as AC­ER-001, be­cause its con­tract pack­ag­ing man­u­fac­tur­er wasn’t ready for an in­spec­tion, ac­cord­ing to the part­ners. The FDA re­quest­ed “ad­di­tion­al ex­ist­ing non­clin­i­cal in­for­ma­tion,” but the com­pa­nies said it was “not an ap­prov­abil­i­ty is­sue.”

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