The FDA recently approved an ORAL therapy, Ekterly (sebetralstat) from KalVista Pharmaceuticals, indicated as an oral treatment for acute hereditary angioedema (HAE) attacks in patients aged 12 and older, after a delay attributed to FDA resource constraints.
HAE is a rare genetic disorder causing C1 esterase inhibitor dysfunction, leading to potentially life-threatening swelling attacks. The approval of Ekterly represents a significant advancement in the management of HAE, offering patients a more convenient, effective, and timely treatment option. This can lead to better overall patient outcomes and an improved quality of life for those affected by this rare genetic disorder. The company is promoting the therapy as a Potential Foundational Treatment with this oral form clinically superior to the time delays associated with injectable alternatives.
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KalVista said the Ekterly will cost $16,720 per dose. The drug will be packaged in a portable blister card that contains two doses.
The company has since disclosed details for logistics and distribution announcing that CVS Specialty, Accredo, Optum, and Orsini have been selected as the specialty pharmacy partners for Ekterly (sebetralstat).
KalVista bounces back from FDA delay with approval for oral rare disease med Ekterly
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