KalVista Pharmaceuticals awarded UK Promising Innovative Medicine (PIM) designation for sebetralstat
KalVista Pharmaceuticals today announced the UK Medicines and Healthcare products Regulatory Agency (MHRA) has awarded the Promising Innovative Medicine (PIM) designation for sebetralstat, an investigational novel, oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE). The PIM is the first step in the Early Access to Medicines Scheme (EAMS) which would allow KalVista to treat patients with sebetralstat prior to receiving a Marketing Authorisation.
Ben Palleiko, Chief Executive Officer of KalVista, said: “We are proud to have sebetralstat designated as a Promising Innovative Medicine by the MHRA, which is similar to Expanded Access in the US. Receiving the PIM designation shows that the MHRA believes that we have a promising candidate for the EAMS to treat people living with HAE.”
The PIM designation also gives companies the opportunity to have early in-depth discussions with both the National Health Service (NHS) and the UK’s Health Technology Agencies.
About the Promising Innovative Medicine Designation
A Promising Innovative Medicine Designation is an early indication that a medicinal product is a promising candidate for the Early Access to Medicines Scheme (EAMS), intended for the treatment, diagnosis or prevention of a life-threatening or seriously debilitating condition with the potential to address an unmet medical need. The designation is issued after an MHRA scientific designation meeting on the basis of non-clinical and clinical data available on the product, in a defined disease area. Following designation, the applicant is expected to complete a clinical development program within a reasonable time period, in order to continue with an application under the EAMS (step II). A designation is a prerequisite to enter the EAMS scientific opinion assessment step.
(Source: KalVista)
