Wikipedia

KalVista Pharmaceuticals said Tuesday that its oral, on-demand treatment for the swelling “attacks” commonly experienced by patients with a genetic condition called hereditary angioedema achieved the goals of a Phase 3 clinical trial.

Based on the study results, the company plans to submit a marketing application to the Food and Drug Administration by the middle of the year. Regulatory filings in Europe and Japan will be completed later in the year.

advertisement

In the Phase 3 study involving 136 participants, a low and high dose of Kalvista’s drug, called sebetralstat, showed a median time to the beginning of symptom relief of 1.6 hours and 1.8 hours, respectively, compared to 6.7 hours for a placebo. The result was statistically significant and achieved the study’s main efficacy goal.

Get unlimited access to award-winning journalism and exclusive events.