FDA to miss approval deadline for Kalvista drug due to ‘resource constraints’
A “heavy workload” and “limited resources” have left the agency unable to meet a June 17 deadline to approve a therapy Kalvista has been developing for hereditary angioedema. Kalvista Therapeutics said Friday that the Food and Drug Administration will miss a deadline to approve its experimental drug for hereditary angioedema because of “resource constraints” at the agency.
According to Kalvista, the FDA notified the company on Thursday that it will be unable to issue a decision on the therapy, called sebetralstat, by June 17 because of a “heavy workload and limited resources.” The regulator expects to deliver a verdict within about four weeks, Kalvista said.
Kalvista claimed the delay isn’t related to any issues with its clinical results and noted that the FDA hasn’t asked the company for any additional data. The only remaining item under FDA review is finalizing the drug’s prescribing information, the company said.
Drug reviews typically follow a predictable timeline. Once an approval application is accepted, the FDA usually decides within six or 10 months whether to clear a new medicine.
The Trump administration’s dramatic downsizing of the FDA earlier this year, however, has sparked concerns about the agency’s ability to meet that goal. Though drug reviewers were supposed to be spared from agency layoffs, many of their supporting employees and teams have been cut.
FDA commissioner Martin Makary has been adamant that drug evaluations aren’t being compromised. “The trains are running on time,” he testified at a Senate hearing last month. Many deadlines have been met so far and, in some cases, drugs have been cleared ahead of schedule.
Still, a few companies — Novavax, GSK, Stealth Biotherapeutics and Vanda Pharmaceuticals — have reported unexpected delays in agency decisionmaking. Kalvista is now part of that group but, unlike the others, said it was specifically told that limited agency resources were the cause. The company had responded to all of the FDA’s requests “in a timely manner,” it said in its statement.
While other deadlines have been missed, “this situation with Kalvista is the first instance that we are aware of that is directly related to resource constraints at the FDA,” wrote Leerink Partners analyst Joseph Schwartz. After connecting with Kalvista management, Schwartz noted that the FDA division reviewing sebetralstat is the same unit that missed a deadline for GSK’s lung disease drug Nucala earlier this year. That division has also simultaneously been reviewing a different hereditary angioedema drug from CSL that has the same June 17 decision deadline.
“Thus, it appears as if this is a division that has been under a heavy workload recently, which has caused some goal dates to be missed,” Schwartz added, adding that his team is “confident in the eventual approval” of sebetralstat.
Kalvista’s drug is meant to be an oral alternative to the injectable medicines typically used to treat the hallmark swelling attacks afflicting people with hereditary angioedema. In testing, sebetralstat proved it could provide comparable symptom relief to those therapies, yet the company has faced persistent questions about the need for its medicine.
Analysts at the investment bank Stifel have estimated that Kalvista’s drug will generate $600 million in annual U.S. sales at its peak.
