WINREVAIR (Merck Sharp & Dohme (Australia) Pty Ltd)
Product name
WINREVAIR
Date registered
Evaluation commenced
Decision date
Approval time
150 (255 working days)
Active ingredients
sotatercept
Registration type
NCE/NBE
Indication
WINREVAIR is indicated for the treatment of adults with pulmonary arterial hypertension (PAH) in WHO Functional Class (FC) II or III, in combination with standard therapy.
Efficacy has been shown in idiopathic and heritable PAH, PAH associated with connective tissue disease, drug or toxin-induced PAH and PAH associated with congenital heart disease with repaired shunts.
Registration process
Priority review
Involves faster TGA evaluation of vital and life-saving medicines for which a complete data dossier is available
Orphan drug
Sponsors receive a fee waiver to help bring medicines for a small population to market.