KalVista Pharmaceuticals has become the latest biotech to face delays to the FDA’s decision-making, as the agency apparently blames a “heavy workload” for pushing back a PDUFA date.
The Cambridge, Mass.-based biotech had been expecting the FDA to make a decision tomorrow, June 17, about whether to approve the oral plasma kallikrein inhibitor sebetralstat for hereditary angioedema (HAE). But KalVista announced Friday that it had been informed by the FDA earlier in the day that it could have to wait up to four weeks for the agency to make the call.
The FDA blamed “heavy workload and limited resources” for the delay, according to KalVista.
The agency hasn’t requested any additional data nor raised any concerns about the drug’s “safety, efficacy or approvability,” the biotech pointed out.
“We are disappointed by this delay, most importantly because we know how much people living with HAE are looking forward to an oral on-demand option to treat their HAE attacks,” KalVista CEO Ben Palleiko said in the company’s release.
“At the same time, we remain confident in the near-term approval of sebetralstat,” Palleiko added. “We are continuing to work closely with the FDA to support the completion of their review.”
The agency has been hit by a wave of layoffs and restructuring so far this year, and recent weeks have seen an uptick in reports of biotechs having key decisions pushed back at the last minute. They include women’s health company Daré Bioscience, which in April blamed FDA delays for postponing a late-stage study for its sexual arousal disorder treatment.
There was also speculation around whether restructuring at the agency was behind the FDA’s move last month to delay an approval decision for Biohaven’s rare disease candidate troriluzole and instead hold an advisory committee to discuss the application.
At the end of March, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced 10,000 layoffs across the federal health agency, including 3,500 full-time FDA employees and 1,200 National Institutes of Health workers. The cuts are on top of 10,000 early retirements or “fork in the road” exits.
A few days later, RFK Jr. walked back 20% of the newly implemented cuts, saying 2,000 of the layoffs were done in error.
Key leadership departures—like former FDA Chief Medical Officer Hilary Marston, M.D., and the agency’s former Center for Biologics Evaluation and Research Director Peter Marks, M.D., Ph.D., among many others—have compounded the mass layoffs.
While the HHS said at the time that the FDA workforce reduction wouldn’t impact drug, medical device or food reviewers, some say it already has.
In April, hundreds of biotech stakeholders penned a letter expressing concerns over the FDA’s capacity after the layoffs with examples from companies that alleged they have already been impacted by the changes at the agency.