Regenxbio Sues FDA Over Clinical Hold on Retinal Disease Treatment

Regenxbio is seeking an injunction against the FDA in a federal court in Washington D.C. to overturn clinical holds the agency placed on two gene therapy INDs for treatment of retinal disease.

The lawsuit in the U.S. District Court for the District of Columbia alleges that the agency placed a full clinical hold on two INDs for RGX-314 on Oct. 18 and later explained that the hold was “associated with their delivery systems” rather than the gene therapy. The agency also said it was “working on addressing the device concerns” involving a third party.

The agency later clarified that only one of the INDs was placed on full clinical hold and that the other was placed on a partial hold. To help clear the way for the IND placed on partial hold, the company simply withdrew the IND on full clinical hold.