Press release
KalVista Submits New Drug Application to FDA for Sebetralstat as First Oral On-demand Treatment for Hereditary Angioedema
CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)-- KalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced the submission of a New Drug
About this update from Kalvista Pharmaceuticals, Inc.
[{"type":"text","content":" CAMBRIDGE, Mass. & SALISBURY, England--(BUSINESS WIRE)--\nKalVista Pharmaceuticals, Inc. (NASDAQ: KALV), today announced the submission of a New Drug Application (NDA) for U.S. Food and Drug Administration (FDA) review of sebetralstat, a novel investigational oral plasma kallikrein inhibitor for the on-demand treatment of hereditary angioedema (HAE) attacks in adults and pediatric patients aged 12 years and older.\n\n\n“This NDA submission represents a pivotal moment not only for our company, but for the entire HAE community as we seek to bring an important therapeutic advancement through the first-ever, oral on-demand treatment for HAE,” said Ben Palleiko, Chief Executive Officer of KalVista. “This achievement is the culmination of the entire KalVista team’s long-term efforts, with the critical support of people living with HAE, as well as our partnerships with the HAE scientific community, the HAEA and HAEi patient advocacy organizations, regulators and other stakeholders, that demonstrate our commitment to addressing persistent unmet needs for people living with this rare disease. If approved, we believe sebetralstat could become a foundational treatment that will transform the way people living with HAE treat their disease.”\n\n\nThe NDA submission is based on previously disclosed clinical trial results, including data from the KONFIDENT phase 3 clinical trial and the KONFIDENT-S extension trial. Sebetralstat met the primary endpoint in the phase 3 trial with both 300 mg and 600 mg formulations achieving the beginning of symptom relief significantly faster than placebo (p12).\n\n\nConsistent with previous studies, sebetralstat was well-tolerated, with a safety profile no different than placebo. There were no treatment-related serious adverse events (SAEs) observed. This favorable safety profile has been consistently observed in all clinical studies for sebetralstat to date.\n\n\nThe FDA has a 60-day filing review period to determine whether the NDA is complete and accepted for review. The Company currently anticipates receiving notification from the FDA on the status of the submission in September. KalVista intends to submit additional marketing authorization applications to other global health authorities throughout 2024.\n\n\nIf approved, sebetralstat would be the first oral, on-demand therapy for people living with HAE. ...