CAMBRIDGE, Mass. & SALISBURY, England - KalVista Pharmaceuticals, Inc. (NASDAQ: NASDAQ:KALV) has received the Promising Innovative Medicine (PIM) designation for sebetralstat from the UK Medicines and Healthcare products Regulatory Agency (MHRA), the company announced today.
This designation is an early step in the Early Access to Medicines Scheme (EAMS), potentially allowing KalVista to treat patients with hereditary angioedema (HAE) before the drug is formally authorized for marketing.
Sebetralstat is an investigational oral treatment designed to inhibit plasma kallikrein, a protein involved in swelling attacks associated with HAE. The PIM designation suggests the MHRA sees promise in the drug as an on-demand treatment for HAE, a rare and potentially life-threatening condition characterized by recurrent swelling attacks.
The PIM status also enables KalVista to engage in early discussions with the National Health Service (NHS) and UK health technology agencies. This step is crucial as it may accelerate the drug's accessibility to patients in need.
The announcement follows recent phase 3 clinical trial results presented by KalVista at the American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting. The trial data reportedly showed significant clinical results across all endpoints, alongside an excellent safety and tolerability profile for the treatment.
Sebetralstat has already garnered attention from regulatory agencies outside the UK, having received Fast Track and Orphan Drug designations from the U.S. Food and Drug Administration (FDA), as well as Orphan Drug Designation and an approved Pediatric Investigational Plan from the European Medicines Agency (EMA).
KalVista, specializing in the development of oral small molecule protease inhibitors, anticipates submitting a new drug application for sebetralstat to the U.S. FDA in the first half of 2024. Submissions for approval in Europe and Japan are expected later in the year.
The information in this article is based on a press release statement from KalVista Pharmaceuticals, Inc.
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