Policy & Regulation
KalVista Pharmaceuticals awarded UK Innovation Passport for sebetralstat
20 February 2024 -

US-based clinical stage pharmaceutical company KalVista Pharmaceuticals Inc (NASDAQ:KALV) announced on Tuesday that it has secured the UK Innovation Passport for sebetralstat, an oral plasma kallikrein inhibitor for treating hereditary angioedema (HAE).

This passport grants access to the UK's Innovative Licensing and Access Pathway (ILAP), expediting market entry and facilitating patient access to new medications.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) issued the Innovation Passport based on positive phase 3 trial data, which demonstrated the efficacy and safety of sebetralstat.

Delivered in partnership by the MHRA, the National Institute for Health and Care Excellence (NICE), the All Wales Therapeutics and Toxicology Centre (AWTTC) and the Scottish Medicines Consortium (SMC), the Innovation Passport prioritises innovative drugs addressing unmet medical needs.

Sebetralstat, already granted Fast Track and Orphan Drug designations by the US Food and Drug Administration (FDA) and Orphan Drug Designation by the European Medicines Agency (EMA), is poised for accelerated development and regulatory processes.