FDA slaps CorMedix with a second manufacturing-related drug rejection

Struggling biotech CorMedix continues to be hampered by what may be a last-ditch effort to gain approval for its DefenCath, an antibacterial and antifungal product developed for the prevention of catheter-related bloodstream infections.

The problem? Continuing manufacturing issues.

On Monday, CorMedix revealed that the FDA had slapped the New Jersey-based company with a second complete response letter. DefenCath can’t be endorsed until CorMedix addresses “deficiencies” at the plant of a contract manufacturer and with the supplier of the active pharmaceutical ingredient (API) heparin, the company said.

It's another blow to CorMedix, which has undergone restructuring—hiring a new CEO and halting its operations in Europe—to focus on the push to get DefenCath to the finish line in the United States.

Three months into his new job, CEO Joe Todisco said in a statement that he is “disappointed,” but also “encouraged” by his discussions with the U.S. regulator.

“I am confident there is a line of sight to FDA approval of the (new drug application) once our existing CMO and API supplier obtain compliance clearance,” Todisco said.

RELATED: CorMedix Announces Pricing of Its Initial Public Offering

CorMedix said that the FDA recently completed an inspection of the plant of its heparin supplier, which resulted in a warning letter for its production of a different API product. The regulator told CorMedix that the deficiencies would have to be resolved before DefenCath can be approved. The supplier has brought in a consultant to address the issues, CorMedix said.

As a backup plan, CorMedix has secured an alternative manufacturer in North Carolina-based CDMO Alcami. The company said that if necessary, it will be able to submit an amendment to its NDA application—making way for Alcami’s production of heparin—in the first quarter of next year.

CorMedix hopes to commercialize DefenCath before the end of 2023, Todisco added.

RELATED: CorMedix Awarded Grants from Federal Qualifying Therapeutic Discovery Project Program

DefenCath, which is intended to treat patients with end-stage renal disease who are receiving hemodialysis through a central venous catheter, has received a fast-track designation from the FDA. It also qualifies as a Qualified Infectious Disease Product (QDIP), which allows for priority review and provides an additional five years of market exclusivity upon its potential approval.