Drug Approvals

Catalyst sues FDA for approving rival drug

Jun 12, 2019

The drama surrounding rival treatments for a rare autoimmune disease is mounting.  

This week, Catalyst Pharmaceuticals announced that it is suing the FDA for approving a drug that directly competes with its own treatment for Lambert-Eaton myasthenic syndrome (LEMS).

The issue was first thrust into the public spotlight back in February when presidential-hopeful Sen. Bernie Sanders called out Catalyst for its $375,000 price tag on Firdapse, a treatment for LEMS that was approved by the FDA in Nov. 2018. Prior to the approval, patients were able to receive a different treatment for LEMS called Ruzurgi, produced by family owned Jacobus Pharmaceuticals, which was free through the FDA’s compassionate use program. Catalyst justified its actions by saying the approval for Firdapse would widen access to the drug.  

Then last month, the FDA made a surprise approval to Ruzurgi for commercial use as well. Although the approval was for pediatric patients, adults could also receive the treatment for off-label use. 

Now, Catalyst says that the FDA approval of Jacobus’ Ruzurgi violates regulations that grant exclusive rights to Catalyst’s Firdapse.  

“We think perhaps the FDA was improperly influenced by political pressure regarding high drug prices and we also feel that this is a horrible precedent for companies that are developing drugs to treat rare diseases,” Catalyst’s CEO told Reuters. 

The company said that it is hoping to reverse the FDA approval of Ruzurgi. 

Read the full Reuters report.