USA — US regulators have rejected a significant drug application from Regeneron Pharmaceuticals Inc. following problems at a production facility operated by Catalent Inc.
This development presents a new challenge for Catalent, one of the leading manufacturing partners in the pharmaceutical industry.
Regeneron had submitted an application, in collaboration with Bayer, for the approval of an 8 mg version of its widely used eye medicine Eylea (aflibercept) in the treatment of wet age-related macular degeneration, diabetic macular edema, and diabetic retinopathy.
Catalent confirmed that its Bloomington, Indiana site was the facility under scrutiny, with the FDA noting three observations during a pre-approval inspection.
In response to the observations, a spokesperson from Catalent emphasized the company’s commitment to taking regulatory matters seriously.
They have already proposed corrective and preventative actions to address the identified issues and expressed support for the FDA’s ongoing review.
The news negatively impacted Catalent’s stock, with shares sliding by 6.4% in New York and experiencing a 13% decline for the year.
The potential delay in approval poses a financial risk for Regeneron, particularly considering the upcoming competition from lower-cost, nearly identical versions of Eylea.
Analysts had relied on the approval of the stronger formulation to help Regeneron maintain its competitive advantage.
This incident is the latest in a series of notable setbacks for Catalent. Previously, deficiencies uncovered during an FDA inspection at the same Bloomington facility resulted in supply disruptions for Moderna Inc.’s Covid booster shot last autumn.
Catalent was also reportedly linked to production issues with Novo Nordisk’s weight-loss drug Wegovy, which faced shortages for approximately one year.
Stephens analyst Jacob Johnson highlighted the impact of inspection findings on high-profile therapies at Catalent sites.
He expressed concerns about the potential effect on the company’s ability to secure future supply deals.
Earlier this year, Catalent reported operational challenges and slowdowns at a gene therapy manufacturing site near Baltimore.
The company also acknowledged productivity issues at its Bloomington and Brussels facilities as it undertakes necessary improvements following regulatory inspections.
In a separate development, the FDA recently issued a Form 483 against an Eli Lilly plant in Indianapolis following an inspection in October.
The FDA staff identified deficiencies in the facility’s drug-filling lines. Additionally, in April, the agency rejected Lilly’s ulcerative colitis prospect mirikizumab due to manufacturing-related shortcomings.
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