In its Citizen Petition to the FDA, Novo Nordisk argued that there is no clinical need to allow compounding for liraglutide, the type 2 diabetes injection it sells as Victoza.
Novo Nordisk last month filed a Citizen Petition with the FDA asking the federal agency to exclude its type 2 diabetes injection Victoza (liraglutide) from a proposed list of drugs eligible for compounding.
The petition comes after the industry group Outsourcing Facilities Association (OFA), which represents FDA-registered compounding pharmacies, nominated liraglutide to the 503B Bulks List, a database of bulk drug substances that can be compounded.
Under normal circumstances, outsourcing facilities are not allowed to compound bulk drug substances, according to the FDA’s website. The 503B Bulks List enumerates substances that are exempted from this rule and is determined according to criteria such as the clinical need for compounding, supply constraints and safety and efficacy issues with the substance proposed for compounding. As per the regulator’s drug shortages database, liraglutide is “currently in shortage.”
In its petition, Novo argued that there is no clinical need to compound liraglutide. “OFA’s nomination cites vague reasons to compound liraglutide,” the company contended, noting that the trade group “recites general attributes unrelated to liraglutide that may make a drug product medically unsuitable and makes broad, boilerplate statements about strength, inactive ingredients, and routes of administration.”
Additionally, the Danish pharma claimed that liraglutide will not lend well to compounding, pointing to “abundant scientific evidence” that even slight tweaks in the manufacturing process “can substantially affect its chemical and physical stability, as well as its impurity profile.”
Compounded liraglutide also raises safety issues, according to Novo, including immunogenicity risks. In its Citizen Petition, the pharma highlighted the 44 documented cases of adverse events linked to unapproved liraglutide since 2017, of which 38 were classified as serious and one ended in death. Compounding might also compromise the efficacy of liraglutide, according to the pharma.
Taken together, these issues suggest that the risks of allowing unapproved liraglutide into the market “far outweigh the purported need for these products” to be compounded, the company argued.
Novo made a similar argument in October 2024 for its star GLP-1 therapy semaglutide, which the pharma said is too complex to compound. In regulatory filings at the time, Novo nominated semaglutide to the FDA’s Demonstrable Difficulties for Compounding (DDC) list, which names drugs that could pose safety risks to the public if manufactured incorrectly—and therefore are exempted from compounding.
Aside from liraglutide, the OFA has also set its sights on Eli Lilly’s blockbuster weight-loss medication tirzepatide, which the FDA in October 2024 formally took off its shortage list. The OFA soon sued the agency, claiming that its decision was “arbitrary” and did not have “any semblance of lawful process.” Last month, the FDA doubled down on its decision to end the shortage for tirzepatide, and on January 1 Lilly asked to join the lawsuit between the OFA and the agency.
