Orladeyo (berotralstat)

Region: 🇪🇺 EU
Active substance: berotralstat
Company: Neopharmed Gentili Ireland Limited
Status: Authorised
Therapeutic area: Angioedemas, Hereditary
CHMP opinion: Thu 25 Feb 2021
EU approval: Fri 30 Apr 2021
Application: EMEA/H/C/005138
ATC: B06AC06
Official record: www.ema.europa.eu

Indication

Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in adult and adolescent patients aged 12 years and older weighing at least 40 kg. Orladeyo is indicated for routine prevention of recurrent attacks of hereditary angioedema (HAE) in: children aged 2 to less than 12 years weighing at least 15 kg adolescents aged 12 and older weighing less than 40 kg

Regulatory milestones

Fri 12 Dec 2025🇺🇸 PDUFA datecompany-announced

ORLADEYO: PDUFA target action date (hereditary angioedema (HAE) in pediatric patients aged 2 to 11 years (oral granules))

Biocryst Pharmaceuticals Inc (BCRX); berotralstat; NDA; status: extended; "The new PDUFA target action date is December 12, 2025."; filed 2025-06-25 · source

Thu 11 Dec 2025🇺🇸 FDA approval

FDA approves Orladeyo (berotralstat dihydrochloride): new dosage form

Biocryst; NDA219776; New dosage form, Priority review; pellets · source

Same substance in other markets

🇺🇸 Orladeyo Approved · Biocryst

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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.