The U.S. Food and Drug Administration (FDA) has missed its scheduled target decision date for GSK's application to expand the use of its IL-5 blocker Nucala (mepolizumab) to include chronic obstructive pulmonary disease (COPD), marking another instance in a growing pattern of regulatory delays.
According to GSK's December 2023 press release announcing the FDA's acceptance of its supplemental application, the regulator was expected to issue a verdict by Wednesday, May 7. However, as of Thursday, no announcement had been made, and GSK confirmed that it has not yet received a decision from the agency.
"The FDA is actively reviewing our submission for Nucala in COPD and we are working closely with them to help bring this important treatment option to patients as quickly as possible," a GSK spokesperson told industry publication Fierce Pharma. "Based on our latest discussions with the FDA, we continue to expect approval."
Nucala's Potential COPD Indication
Nucala (mepolizumab) is already approved for several conditions, including severe eosinophilic asthma, but its expansion into COPD would represent a significant advancement for patients with this progressive respiratory disease. COPD affects millions of Americans and is characterized by persistent respiratory symptoms and airflow limitation due to airway and/or alveolar abnormalities.
The application seeks approval for Nucala as an add-on maintenance treatment for patients with COPD who have an eosinophilic phenotype. Eosinophils are white blood cells that can contribute to inflammation in the lungs, and targeting them with an IL-5 blocker like Nucala could potentially reduce exacerbations in a subset of COPD patients.
Pattern of FDA Regulatory Delays
The delay in GSK's application review is not an isolated incident. The FDA has recently demonstrated a pattern of missed deadlines and regulatory lapses across multiple applications:
In April, the agency failed to provide Novavax with a verdict for its updated COVID-19 vaccine by the target date of April 1. The vaccine remains in regulatory limbo, though Novavax maintains that the shot is "approvable" and has revealed that the FDA requested a post-marketing commitment to collect additional data.
Similarly, the FDA missed its target decision date for Stealth BioTherapeutics' elamipretide, an investigational drug for the ultra-rare Barth Syndrome. The regulator informed the company on the scheduled decision day (April 29) that it would not meet the target action date.
Earlier this week, the FDA published a Federal Register notice for an upcoming vaccine advisory committee meeting scheduled for May 22, but the posting fell short of the customary 15-day advance notice requirement. The agency acknowledged this failure, attributing it to "technical issues" but is proceeding with the meeting due to "exceptional circumstances."
FDA Staffing Challenges
These regulatory delays coincide with significant staffing challenges at the FDA. Since Robert F. Kennedy Jr. assumed the role of Secretary of Health and Human Services in February, the FDA has reportedly lost approximately 3,500 employees to layoffs, with the actual number potentially higher due to voluntary departures.
The reduction in workforce raises concerns about the agency's capacity to maintain its regulatory functions and adhere to review timelines, potentially affecting numerous pharmaceutical companies awaiting decisions on their products.
Implications for Patients and Industry
For patients with COPD who might benefit from Nucala, the delay extends the wait for a potential new treatment option. For GSK, the delay impacts commercialization plans and potentially affects revenue projections for the expanded indication.
More broadly, the pattern of regulatory delays creates uncertainty for the pharmaceutical industry, potentially affecting investment decisions, clinical development strategies, and ultimately the pace at which new treatments reach patients.
Industry observers will be watching closely to see how the FDA addresses these challenges and whether additional resources or process changes will be implemented to restore the agency's ability to meet its regulatory commitments consistently.
