Press release
KalVista Pharmaceuticals Announces UK MHRA Approval of EKTERLY® (sebetralstat), First and Only Oral On-demand Treatment for Hereditary Angioedema
EKTERLY to be added to the Orphan Register and awarded 10 years of market exclusivity CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista
About this update from Kalvista Pharmaceuticals, Inc.
[{"type":"text","content":"\nEKTERLY to be added to the Orphan Register and awarded 10 years of market exclusivity\n\n\n CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--\nKalVista Pharmaceuticals, Inc. (Nasdaq: KALV) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) has granted marketing authorization for EKTERLY® (sebetralstat), a novel plasma kallikrein inhibitor, for the treatment of hereditary angioedema (HAE) attacks in adults and adolescents aged 12 years and older. EKTERLY is the first and only oral on-demand treatment for HAE approved in the UK.\n\n\n“The approval of EKTERLY in the United Kingdom builds on our recent FDA approval and advances our global commitment to bring this innovative treatment option to people living with HAE,” said Ben Palleiko, CEO of KalVista. “This approval holds particular significance for KalVista as EKTERLY was discovered in our Salisbury, UK labs—making it even more exciting that now we will be able to offer this therapy to people living with HAE in the UK. More broadly, this is another example of the incredible skills of our entire team in pursuing what we expect to be the fastest global launch of an HAE therapy ever.”\n\n\nThe MHRA’s marketing authorization for EKTERLY is based on results from the phase 3 KONFIDENT clinical trial, which was the largest clinical study ever conducted in HAE. Data from KONFIDENT was published in the New England Journal of Medicine in May 2024, showing that EKTERLY achieved significantly faster symptom relief, reduction in attack severity and attack resolution than placebo, and was well-tolerated with a safety profile similar to placebo. The trial randomized 136 HAE patients from 66 clinical sites across 20 countries.\n\n\n“The MHRA approval of EKTERLY brings us one step closer to having an oral on-demand treatment available to patients in the UK for the first time,” said Dr. Sinisa Savic, Professor of Clinical Immunology, St James's University Hospital Leeds and sebetralstat investigator. “I look forward to seeing the impact this new treatment option will have on the HAE community in the UK.”\n\n\nEKTERLY also met the requirements of the MHRA Orphan Designation criteria and will be added to the Orphan Register held by the MHRA, allowing it to benefit from up to 10 years of market exclusivity.\n\n\nIn March of this yea...