Cat­a­lyst wins re­ver­sal in or­phan ex­clu­siv­i­ty court bat­tle with FDA

A US ap­peals court on Thurs­day af­ter­noon over­turned a pri­or FDA court win, say­ing that the agency nev­er should’ve ap­proved a rare dis­ease drug be­cause a pre­vi­ous­ly ap­proved but pricey drug with the same ac­tive in­gre­di­ent has or­phan drug ex­clu­siv­i­ty bar­ring such an ap­proval.

The case con­cerns Cat­a­lyst Phar­ma­ceu­ti­cals, which sued the FDA in June 2019 be­cause the FDA ap­proved ri­val Ja­cobus Phar­ma­ceu­ti­cal’s copy­cat Ruzur­gi (am­i­fam­pri­dine) for the treat­ment of LEMS. Cat­a­lyst claimed that the or­phan drug ex­clu­siv­i­ty on its com­pet­ing but more ex­pen­sive LEMS treat­ment Fir­dapse (am­i­fam­pri­dine) should have barred Ja­cobus from win­ning ap­proval for Ruzur­gi.

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