The Holy Grail is Here: FDA Approves KalVista’s First-Ever Pill for Painful HAE Swelling Attacks

BOSTON, MA – Patients suffering from hereditary angioedema (HAE) have cause for celebration today. The FDA has approved KalVista Pharmaceuticals’ Ekterly, the first and only oral pill designed to stop the painful and debilitating swelling attacks associated with the rare genetic disease.

Hailed by one analyst as the “holy grail in HAE,” Ekterly represents a monumental leap forward in treatment. For years, patients have had to rely on cumbersome injections and infusions that are difficult to administer and carry, often leading to delayed treatment. KalVista’s simple, on-demand pill promises to change everything.

“Convenience and route of administration are major shortcomings of the legacy treatment options, and we see a significant opportunity for oral Ekterly,” said Leerink Partners analyst Joseph Stringer.

The approval follows a challenging journey that saw the FDA delay its decision, causing investor concern. However, the final green light was decisive and came with a “clean” label, allowing the pill to be used for swelling attacks anywhere in the body.

The news was met with immediate enthusiasm on Wall Street, with shares of KalVista (KALV) jumping more than 16%. Analysts see a blockbuster in the making, with peak sales forecasts ranging from $470 million to $700 million.

For the thousands of HAE patients seeking a better way to manage their condition, the arrival of Ekterly is more than just good news—it’s the breakthrough they’ve been waiting for.