In a blow to Catalyst Pharmaceuticals (CPRX), a federal judge dismissed its lawsuit accusing the Food and Drug Administration of violating the law when it approved a similar medicine by a small, family-run rival company.
The lawsuit has been closely watched because Catalyst raised thorny questions about regulatory standards and the vagaries of orphan drug designations, while also playing into the heated national debate over the rising cost of prescription medicines. But in an 18-page order, U.S. District Court Judge Beth Bloom maintained Catalyst staked out differing interpretations of federal law and FDA regulations that did not support its case.
At issue was the May 2019 FDA approval of a Jacobus Pharmaceuticals drug used to treat a rare neuromuscular disorder called Lambert-Eaton myasthenic syndrome, or LEMS, that afflicts a few hundred to a few thousand people in the U.S. With its endorsement, the FDA provided Catalyst with unexpected competition after winning approval for its own medicine just months earlier.
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