In December, Danish pharmaceutical giant Novo Nordisk A/S (NYSE:NVO) submitted a Citizen Petition to the FDA requesting the exclusion of liraglutide from the 503B Bulks List, a registry of substances that outsourcing facilities may use in drug compounding.
The petition argues that FDA-approved liraglutide-based products, Victoza, Saxenda, and Xultophy, meet the needs of patients without requiring additional compounded versions, which Novo Nordisk contends pose significant safety and efficacy risks.
Teva Pharmaceuticals (NYSE:TEVA) markets an authorized generic of Victoza.
A Phase 2b clinical trial presented at the Alzheimer's Association International Conference 2024 revealed that liraglutide may slow cognitive decline by protecting the brain.
The company highlights that existing FDA-approved formulations lack attributes that would necessitate compounding, while the Outsourcing Facilities Association's (OFA) nomination relies on generalized, unsupported claims.
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Novo Nordisk asserts that compounded liraglutide products have a history of safety concerns, including adverse events and immunogenicity risks stemming from impurities and fibril formation.
The petition cites evidence of unapproved liraglutide products' instability and diminished potency.
Testing has shown reduced bioavailability due to impurities and fibril formation, rendering these products less effective or ineffective for conditions such as type 2 diabetes, cardiovascular disease, and chronic weight management.
Novo Nordisk also noted 44 documented adverse events associated with compounded liraglutide since 2017, including 38 serious cases and one death.
Novo Nordisk warns that adding liraglutide to the 503B Bulks List would contradict Congress' and the FDA's intent to restrict patient exposure to unapproved drugs.
The company argues that such an action would undermine incentives for pharmaceutical innovation while increasing risks to public health.
Novo Nordisk further calls for rescission of the FDA's 503B Interim Policy, which it claims creates unauthorized pathways for compounding drugs without statutory approval.
The petition also urges the FDA to refrain from categorizing liraglutide under the 503B Interim Policy's Category 1, including substances with pending clinical need evaluations.
Novo Nordisk highlights OFA's failure to provide adequate data justifying liraglutide's inclusion and the risks posed by unapproved compounded products, suggesting that liraglutide be placed in Category 2 due to its significant safety risks.
Price Action: NVO stock is down 0.46% at $87.25 during the premarket session at last check Monday.
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