Novo Nordisk Pushes FDA To Exclude Compounding For Its Early-Technology Diabetes Drug – Novo Nordisk (NYSE:NVO)

In December, Danish pharmaceutical large Novo Nordisk A/S NVO submitted a Citizen Petition to the FDA requesting the exclusion of liraglutide from the 503B Bulks Record, a registry of gear that outsourcing services might use in drug compounding.

The petition argues that FDA-approved liraglutide-based merchandise, Victoza, Saxenda, and Xultophy, meet the wants of sufferers with out requiring extra compounded variations, which Novo Nordisk contends pose important security and efficacy dangers.

Teva Prescription drugs TEVA markets a licensed generic of Victoza.

A Section 2b scientific trial introduced on the Alzheimer’s Affiliation Worldwide Convention 2024 revealed that liraglutide might gradual cognitive decline by defending the mind.

The corporate highlights that current FDA-approved formulations lack attributes that will necessitate compounding, whereas the Outsourcing Amenities Affiliation’s (OFA) nomination depends on generalized, unsupported claims.

Additionally Learn: Novo Nordisk’s Older Technology Weight-Loss Drug Saxenda Related With Decreased Bone Mass Density, Examine Reveals

Novo Nordisk asserts that compounded liraglutide merchandise have a historical past of security considerations, together with opposed occasions and immunogenicity dangers stemming from impurities and fibril formation.

The petition cites proof of unapproved liraglutide merchandise’ instability and diminished efficiency.

Testing has proven diminished bioavailability as a result of impurities and fibril formation, rendering these merchandise much less efficient or ineffective for circumstances corresponding to kind 2 diabetes, heart problems, and continual weight administration.

Novo Nordisk additionally noted 44 documented opposed occasions related to compounded liraglutide since 2017, together with 38 critical circumstances and one demise.

Novo Nordisk warns that including liraglutide to the 503B Bulks Record would contradict Congress’ and the FDA’s intent to limit affected person publicity to unapproved medication.

The corporate argues that such an motion would undermine incentives for pharmaceutical innovation whereas growing dangers to public well being.

Novo Nordisk additional requires rescission of the FDA’s 503B Interim Coverage, which it claims creates unauthorized pathways for compounding medication with out statutory approval.

The petition additionally urges the FDA to chorus from categorizing liraglutide underneath the 503B Interim Coverage’s Class 1, together with substances with pending scientific want evaluations.

Novo Nordisk highlights OFA’s failure to supply enough knowledge justifying liraglutide’s inclusion and the dangers posed by unapproved compounded merchandise, suggesting that liraglutide be positioned in Class 2 as a result of its important security dangers.

Value Motion: NVO inventory is down 0.46% at $87.25 in the course of the premarket session eventually examine Monday.

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