(Reuters) – Catalyst Pharmaceuticals Inc said on Wednesday it has filed a lawsuit against the U.S. Food and Drug Administration, challenging the recent approval of Jacobus Pharmaceutical Co’s drug, Ruzurgi, for a rare neuromuscular disease.
Shares of Catalyst fell nearly 1.3% in early trading and has lost about 40% of its value since Ruzurgi was approved in May.
The lawsuit alleges that the approval of Ruzurgi violated multiple provisions of FDA regulations and Catalyst’s rights to exclusivity for a similar drug, Firdapse.
However, Firdapse’s $375,000 a year price tag has drawn criticism, including from presidential candidate and U.S. senator Bernie Sanders.
Before the drug’s launch last year, patients were able to get the same drug for free from Jacobus, which offered it through an FDA program called “compassionate use”.
Both the drugs – Firdapse and Ruzurgi – are approved to treat Lambert-Eaton myasthenic syndrome, but Firdapse was approved for adults, while Jacobus’ drug was approved for children.
“The FDA has misapplied its regulations, contradicting decades of precedent and has undercut Catalyst’s orphan drug exclusivity,” the company, which filed the lawsuit in the United States District Court for the Southern District of Florida, said in a statement.
An FDA spokeswoman declined to comment.
Reporting by Saumya Sibi Joseph in Bengaluru and Michael Erman in New York; Editing by Arun Koyyur