Updates provided on sebetralstat, an HAE medicine currently being used by people, by manufacturer
[Sebetralstat is also often referred to by its brand name, Ekterly]
A series of updates on sebetralstat, which has recently been approved for the treatment of HAE, were provided by the pharmaceutical company KalVista. The key updates shared were:
- FDA approval and US launch of sebetralstat, a novel plasma kallikrein inhibitor for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older, took place on 7 July 2025
- In July 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) of the United Kingdom (UK) granted marketing authorization for sebetralstat. Sebetralstat 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.
- Also in July 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending marketing authorization for sebetralstat. The European Commission (EC) final decision is expected in October 2025.
- The Committee for Orphan Medicinal Products (COMP) of the EMA confirmed maintenance of orphan designation for sebetralstat. This designation secures important regulatory and financial benefits, including 10 years of EU market exclusivity, making sebetralstat one of only two HAE medicines to retain orphan status.
Ben Palleiko, CEO of KalVista, said: “This quarter marked a defining moment in the history of KalVista with the FDA approval of Ekterly — the first and only oral on-demand treatment for HAE. Approval and launch on the same day propelled us immediately into our next chapter and the response has been extraordinary. This early demand has exceeded our expectations, validating both the urgent unmet need that Ekterly addresses and its potential to redefine management of HAE.”
(Source: KalVista)