EKTERLY (JACE Pharma Pty Ltd)
Product name
EKTERLY
Sponsor
Date registered
Evaluation commenced
Decision date
Approval time
183 (255 working days)
Active ingredients
sebetralstat
Registration type
NCE/NBE
Indication
Ekterly is indicated for the treatment of hereditary angioedema (HAE) attacks caused by C1 inhibitor deficiency or dysfunction in patients aged 12 years and older.
Registration process
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.