FDA approves new drug for hypoparathyroidism, a rare disorder

FDA approved Yorvipath (palopegteriparatide) injection for subcutaneous use in adults with hypoparathyroidism — the first FDA-approved hormone replacement for adults with the rare disorder. The approval drew on an 82-patient, 26-week trial in which 69% of Yorvipath patients versus 5% of placebo patients maintained normal calcium without active vitamin D or high-dose calcium supplements. The application received orphan drug designation and priority review; the drug was not studied in acute post-surgical hypoparathyroidism.