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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