De nieuwe concurrent voor Pharming die een oraal toe te dienen pil heeft tegen acute HAE aanvallen heeft naast de US (juni 2025 mogelijk goedkeuring) naast de EU ook autorisatie aangevraagd in de UK, Zwitserland Australië en Singapore.
Kalvista asks 4 countries to OK sebetralstat as treatment for HAE
Approval sought in UK, Switzerland, Australia, Singapore
Kalvista Pharmaceuticals has submitted applications to regulatory authorities in the U.K., Switzerland, Australia, and Singapore requesting the approval of sebetralstat, an oral, on-demand treatment for hereditary angioedema (HAE) in patients ages 12 and older.
The four applications were submitted through the Access Consortium framework, a coalition of regulatory authorities working together to promote and maximize collaboration across countries and support a timely regulatory review process.
Regulatory authorities in the U.S. and the European Union have agreed to review similar applications requesting sebetralstat’s approval. A decision from the U.S. Food and Drug Administration (FDA) is expected by June 17, 2025.