Humacyte's Symvess receives US Defense Logistics Agency's ECAT listing approval.

Humacyte's Symvess, a bioengineered tissue product, has been awarded Electronic Catalog listing approval from the US Defense Logistics Agency. This makes Symvess available to healthcare professionals treating military personnel, veterans, and other patients at DOD and VA facilities. Symvess was FDA-approved for extremity vascular trauma in December 2024.

KalVista Pharmaceuticals has received a significant milestone with the US Food and Drug Administration (FDA) approval of Ekterly (sebetralstat) for the treatment of acute hereditary angioedema (HAE) attacks in patients aged 12 and above. This approval represents a major advancement in the management of HAE, offering patients an oral on-demand therapy for the first time in the US.

Ekterly, a plasma kallikrein inhibitor, is designed to address the unpredictable nature of HAE attacks and the need for immediate access to medication. The drug's approval follows the successful completion of the Phase 3 KONFIDENT clinical trial, which demonstrated that Ekterly provided faster symptom relief and reduced attack severity compared to placebo. The trial's results, published in the New England Journal of Medicine in May 2024, also indicated that the drug was well-tolerated with a safety profile similar to placebo [1].

KalVista plans to launch Ekterly immediately, allowing healthcare professionals to start prescribing the drug for the treatment of HAE attacks. The company's CEO, Ben Palleiko, expressed gratitude for the FDA approval, emphasizing the potential of Ekterly to become the foundational treatment for HAE. KalVista has also initiated the KalVista Cares program, offering personalized services and resources, including help with insurance coverage, to support patients throughout their treatment journey.

The approval of Ekterly underscores the company's commitment to the HAE community and its dedication to developing innovative treatments. The drug's oral on-demand nature provides patients with greater independence and control over managing their condition, aligning with treatment guidelines and reducing the overall burden of disease.

References:
[1] https://www.worldpharmaceuticals.net/news/kalvista-secures-fda-approval-for-ekterly-to-treat-hae-attacks/