KalVista Pharmaceuticals Awarded UK Promising Innovative Medicine (PIM) Designation for Sebetralstat
– Full EAMS designation would allow treatment of patients with sebetralstat prior to receiving a Marketing Authorization from
“We are proud to have sebetralstat designated as a Promising Innovative Medicine by the MHRA, which is similar to Expanded Access in the US,” said Ben Palleiko, Chief Executive Officer of KalVista. “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.
KalVista recently provided phase 3 data for sebetralstat at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, which displayed clinically and statistically significant results across all endpoints, and an excellent safety and tolerability profile.
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.
About Sebetralstat
Discovered by KalVista, sebetralstat is an investigational novel, oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE). Sebetralstat has received Fast Track and Orphan Drug designations from the
About KalVista Pharmaceuticals, Inc.
KalVista Pharmaceuticals, Inc. is a pharmaceutical company focused on the discovery, development, and commercialization of oral, small molecule protease inhibitors for diseases with significant unmet need. KalVista disclosed positive phase 3 data for the KONFIDENT trial for its oral, on-demand therapy sebetralstat in February 2024. The Company anticipates submitting a new drug application to the
For more information about KalVista, please visit www.kalvista.com.
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KalVista Pharmaceuticals, Inc.
Jarrod Aldom
Vice President, Corporate Communications
(201) 705-0254
jarrod.aldom@kalvista.com
Ryan Baker
Head, Investor Relations
(617) 771-5001
ryan.baker@kalvista.com
Source: KalVista Pharmaceuticals, Inc.