FDA Delays Decision on Kalvista's Hereditary Angioedema Drug, Citing Resource Constraints

The U.S. Food and Drug Administration (FDA) has announced it will miss the approval deadline for Kalvista Therapeutics' experimental drug sebetralstat, developed for the treatment of hereditary angioedema. The delay, attributed to "resource constraints" at the agency, marks a significant development in the pharmaceutical industry and raises questions about the FDA's capacity to meet review timelines.

FDA Cites "Heavy Workload and Limited Resources"

Kalvista Therapeutics reported on Friday that the FDA had notified them of their inability to meet the June 17 deadline for a decision on sebetralstat. The agency cited a "heavy workload and limited resources" as the primary reasons for the delay. According to Kalvista, the FDA expects to deliver a verdict within approximately four weeks.

The company emphasized that the delay is not related to any issues with their clinical results, and the FDA has not requested additional data. The only remaining item under review is the finalization of the drug's prescribing information.

Impact of FDA Downsizing on Drug Reviews

This delay comes in the wake of the Trump administration's significant downsizing of the FDA earlier this year. While drug reviewers were supposedly spared from agency layoffs, many supporting employees and teams have been cut, raising concerns about the agency's ability to meet its review goals.

FDA Commissioner Martin Makary has maintained that drug evaluations are not being compromised, stating in a recent Senate hearing that "the trains are running on time." However, Kalvista's case is not isolated. Other companies, including Novavax, GSK, Stealth Biotherapeutics, and Vanda Pharmaceuticals, have also reported unexpected delays in agency decision-making.

Sebetralstat: A Potential Oral Alternative for Hereditary Angioedema

Kalvista's sebetralstat is positioned as an oral alternative to the injectable medicines typically used to treat hereditary angioedema, a rare genetic disorder characterized by sudden attacks of swelling in various body parts. In clinical trials, sebetralstat demonstrated comparable symptom relief to existing therapies.

Despite the promising results, the company has faced persistent questions about the need for its medicine in a market dominated by injectable treatments. Analysts at Stifel have estimated that sebetralstat could generate $600 million in annual U.S. sales at its peak, underscoring the potential significance of this drug in the pharmaceutical landscape.