KalVista Pharmaceuticals reports first fiscal quarter results and provides operational update
KalVista Pharmaceuticals today provided an operational update and released financial results for the first fiscal quarter ended 31 July 2024.
Ben Palleiko, CEO of KalVista, said: “We are excited about the steady progress we’ve made over the last few months including the most recent acceptance of our NDA by FDA and the EMA’s validation of our MAA.
“We look forward to building on these recent milestones as we move toward filing for approval in the UK, Japan, and other countries later in 2024 and aim for our first commercial launch of sebetralstat in June 2025. I am grateful for the hard work of the entire KalVista team as we remain dedicated to getting this important treatment to people living with HAE.”
Recent Business Highlights:
Sebetralstat
- In September, KalVista announced the US Food and Drug Administration (FDA) accepted its New Drug Application (NDA) for sebetralstat, a novel, investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adult and pediatric patients aged 12 years and older. The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of 17June 2025.
- Last month, the Company announced that the European Medicines Agency (EMA) validated the submission of the Marketing Authorization Application (MAA) for sebetralstat.
- KalVista expects to file for approval in the UK, Japan, and other countries later in 2024. The Company has also engaged with the Access Consortium to maximize regulatory collaboration across countries and support a timely review process.
- In June, ahead of schedule, KalVista initiated a pediatric clinical trial (KONFIDENT-KID) using an orally disintegrating tablet (ODT) formulation of sebetralstat designed for this population. KONFIDENT-KID will enroll approximately 24 children, with an age range of 2 to 11 years, across seven countries in North America, Europe and Asia. The trial has since started dosing patients and if approved, sebetralstat would be the first oral, on demand treatment for this population and only the second approved on-demand therapy of any type.
- Data from the phase 3 KONFIDENT trial of sebetralstat was published in the New England Journal of Medicine (NEJM) and presented at the European Academy of Allergy and Clinical Immunology Congress 2024 (EAACI).
(Source: KalVista)