As part of the Commissioner's National Priority Review Voucher program, the agency had expedited review of the blood disorder therapy. The FDA has rejected a rare disease therapy from Disc Medicine, an early recipient of a commissioner's voucher from the agency. The FDA, in its letter rejecting bitopertin, cited “uncertainties” about the correlation between the blood-based biomarker used as the efficacy goal in Disc’s clinical trials and clinical benefit for patients. WASHINGTON — The Food and Drug Administration on Friday rejected bitopertin, a therapy developed by Disc Medicine to treat the rare blood disorder porphyria, which makes patients extremely sensitive to sunlight.

Original title: “FDA rejects rare disease therapy from Disc Medicine, early recipient of commissioner’s voucher”