Xentria gets US FDA orphan drug designation for XTMAB-16 in sarcoidosis

Xentria announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) for its intravenous TNF-α inhibitor, XTMAB-16, for the treatment of sarcoidosis. TNF-α is a proinflammatory cytokine that has been implicated in the pathogenesis of sarcoidosis and associated granuloma formation.

We are pleased the FDA has granted Orphan Drug Designation for XTMAB-16 for the treatment of sarcoidosis, as it reaffirms the need for an effective therapy for patients with this potentially life-threatening inflammatory disease. This is an important regulatory milestone for our company, and we look forward to advancing XTMAB-16 into the clinical phase,” said Thomas Shea, President of Xentria.

Founded in April 2020, Xentria’s primary focus is on building biologics and biosimilars to treat rare diseases, immunologic, metabolic, musculoskeletal disorders, and certain types of cancer.

The FDA Office of Orphan Products Development grants orphan status to drugs which are being developed to treat rare disorders affecting fewer than 200,000 people in the U.S., addressing unmet medical needs for these patients.

This designation provides certain benefits to the drug developer, including seven years of market exclusivity upon FDA approval, prescription drug user fee waivers and tax credits for qualified clinical trials.