Dis­trict Court throws out Cat­a­lyst law­suit al­leg­ing im­prop­er ap­proval stan­dards for ri­val LEMS drug

Cat­a­lyst Phar­ma­ceu­ti­cals re­ceived bad news Tues­day af­ter­noon as a fed­er­al judge threw out their law­suit ac­cus­ing the FDA of il­le­gal­ly ap­prov­ing a ri­val drug.

The case dealt with the agency’s thumbs-up of the Ja­cobus drug Ruzur­gi to treat Lam­bert-Eaton myas­thenic syn­drome, a rare neu­ro­mus­cu­lar dis­or­der, in chil­dren. Cat­a­lyst had al­leged the ap­proval vi­o­lat­ed the sev­en-year mar­ket ex­clu­siv­i­ty win­dow pro­vid­ed to its own LEMS drug Fir­dapse, and that reg­u­la­tors had used dif­fer­ent ap­proval stan­dards for the drugs by con­sid­er­ing Fir­dapse’s high price tag in its Ruzur­gi de­ci­sion.

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