for hereditary angioedema
Sponsor announced submission . FDA filing review (~60 days) in progress; PDUFA date estimated as acceptance + 10 months Standard Review. Card updates with confirmed dates when FDA acceptance announcement lands.
Hereditary angioedema (HAE) causes sudden, dangerous swelling attacks in the skin, airways, and digestive tract that can last for days. Lonvoguran ziclumeran is a gene therapy designed to deliver working copies of the faulty SERPING1 gene, which normally produces a protein that controls swelling. By restoring this natural "off switch" for inflammation, the treatment could potentially prevent future attacks and reduce reliance on emergency medications.