FDA Delays Approval of GSK's Nucala for COPD, Raising Concerns Over Regulatory Efficiency

May 10, 2025 06:06 CST Updated 06:06

GSK

Pharmaceutical R&D Manufacturer

In the biopharmaceutical industry, the approval efficiency of the U.S. Food and Drug Administration (FDA) has always been a focus of attention. Recently, the FDA once again failed to make an approval decision on GlaxoSmithKline PLC.'s (GSK) drug Nucala on time. This incident not only affected GSK's business progress but also raised questions about the FDA's approval process.

Approval Delays Halt GSK's New Drug Launch Process

GSK has long hoped to expand the scope of its IL-5 blocker Nucala for the treatment of chronic obstructive pulmonary disease. According to a press release issued by GSK in December 2024, the FDA was expected to make a decision on this application by May 7, 2025. However, as of May 7, the FDA had not announced any decision. Multiple media outlets reported on this on May 8, and a GSK spokesperson confirmed to Fierce Pharma that the company had not yet received a decision from the FDA. The spokesperson did not provide further comments on discussions with regulators but stated that the FDA is actively reviewing the application and the company still expects the application to be approved.

Frequent delays, approval issues exposed one after another

This is not the first time the FDA has experienced approval delays recently. Last month, the FDA failed to make a decision on Novavax's updated COVID-19 vaccine by the April 1 deadline. The vaccine’s approval remains unresolved, even though Novavax maintains that the vaccine could be approved, but the FDA has requested more data to be collected post-market. Additionally, the FDA also missed the April 29 deadline for Stealth BioTherapeutics' drug elamipretide, intended to treat Barth syndrome, only notifying the company on the same day that it could not complete the review on time.

In addition to the delays in drug approvals, the FDA has encountered issues in other areas as well. This week, the FDA issued a notice for a vaccine advisory meeting, but the release was only 14 days before the meeting, falling short of the standard 15-day advance notice. The FDA acknowledged that a technical issue caused the delay in the announcement but stated that, due to special circumstances, the meeting would proceed as scheduled.

Impact of Layoffs May Affect Approval Efficiency

Since Robert F. Kennedy Jr. took office as the U.S. Secretary of Health and Human Services in February this year, the FDA has laid off approximately 3,500 employees, with the actual number potentially higher due to voluntary departures. The significant personnel changes may impact the FDA’s approval process. Many industry insiders speculate that staff shortages caused by the layoffs could be one of the key reasons for approval delays. Given that the approval process requires substantial involvement from specialized personnel, a reduction in workforce might lead to a backlog of work, thereby affecting approval efficiency.

The consecutive approval delays by the FDA have drawn widespread attention from the biopharmaceutical industry. This has not only hindered the R&D and commercial plans of relevant companies but also potentially affected public trust in the FDA's regulatory capacity. In the future, the FDA needs to address these issues as soon as possible.

Reference Source:https://www.biospace.com/fda/fda-delays-continue-as-regulator-misses-review-date-for-gsks-nucala

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