KalVista Pharmaceuticals awarded UK innovation passport for sebetralstat

KalVista Pharmaceuticals today announced the UK Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the Innovation Passport for sebetralstat, an investigational novel, oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE).

The Innovation Passport is the first step in the UK’s Innovative Licensing and Access Pathway (ILAP), which is designed to accelerate a product’s time to market and facilitate patient access to innovative medicines.

Andrew Crockett, Chief Executive Officer of KalVista, said: “As a company which has its roots in the UK, we are pleased to receive the ILAP designation, which will enable us to further accelerate our regulatory submission for sebetralstat. We look forward to collaborating with the MHRA and other health regulatory agencies worldwide as we continue to work towards bringing the first oral, on demand treatment to people living with HAE.”

About the Innovation Passport

Delivered in partnership by the All Wales Therapeutics and Toxicology Centre (AWTTC), the Medicines and Healthcare products Regulatory Agency (MHRA), the National Institute for Health and Care Excellence (NICE) and the Scottish Medicines Consortium (SMC), the Innovation Passport prioritizes innovative medicines in development for the treatment of diseases for patients with significant unmet need. Benefits of the ILAP include opportunities for enhanced regulatory and other stakeholder access with the aim of accelerating the time it takes for a product to reach the market, thereby boosting patients’ access to innovative medicines.

(Source: KalVista)