The missed PDUFA adds to a string of delays at the FDA in recent weeks, including at least two other missed target action dates.
The FDA has missed another target decision date, this time for GSK, which is looking to expand its IL-5 blocker Nucala into chronic obstructive pulmonary disease.
As per a December 2024 press release from GSK announcing the FDA’s acceptance of its application, the regulator should have released a verdict on Wednesday, May 7. But several media outlets on Thursday reported that an announcement has yet to be made.
In a statement to Fierce Pharma, a GSK spokesperson confirmed that the company has not received a decision from the FDA, but noted that it does “not comment on ongoing discussions with regulatory authorities.”
“The FDA is actively reviewing our submission for Nucala in COPD [chronic obstructive pulmonary disease] and we are working closely with them to help bring this important treatment option to patients as quickly as possible,” the spokesperson told Fierce. “Based on our latest discussions with the FDA, we continue to expect approval.”
BioSpace has reached out to GSK for independent confirmation of the delay and will update this article accordingly.
The FDA in recent weeks has started to show lapses in its regulatory function and delays with its review process. Last month, for instance, the agency failed to provide Novavax with a verdict for its updated COVID-19 shot by the target date of April 1. The vaccine remains in limbo, though the company stands by its application—in late April, Novavax insisted that the shot was “approvable” and revealed that the FDA has asked for a post-marketing commitment to collect additional data.
The agency similarly failed to meet its target decision date for Stealth BioTherapeutics’ elamipretide, an investigational drug for the ultra-rare disease Barth Syndrome. According to the biotech’s news release, the FDA should have released a verdict on April 29—but the regulator informed the company on the day itself that it would not meet that target action date.
Earlier this week, the FDA put out a Federal Register notice announcing an upcoming meeting for its vaccine advisers. The posting, however, fell short of the customary 15-day advance notice for such meetings. The panel discussion is scheduled for May 22, while the Register notice was posted on May 8.
The FDA itself conceded that it came up short: “FDA regrets that it was unable to publish this notice 15 days prior to the [meeting] due to technical issues.” Still, the agency is pushing through with the meeting, citing the “exceptional circumstances” that warrant the expert discussion.
Since Robert F. Kennedy Jr. assumed the role of Secretary of Health and Human Services in February, the FDA has lost some 3,500 employees to layoffs, though the number is likely higher owing to voluntary exits.
