Earlier, Novo Nordisk A/S NVO petitioned the FDA to ban compounding pharmacies from producing cheaper, unapproved variations of its medicine Wegovy and Ozempic.
Amid shortages and rising demand for branded medicine, compounded semaglutide has gained reputation as a result of its affordability.
Nonetheless, Novo Nordisk contends that solely FDA-approved variations needs to be obtainable, emphasizing the protection dangers related to compounded medicine.
Novo Nordisk’s Chief Monetary Officer Karsten Munk Knudsen has reportedly confirmed that the corporate was conscious of at the least ten deaths and 100 hospitalizations linked to those compounded variations of semaglutide-based medicine.
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Nonetheless, he famous that no definitive explanation for dying is recognized within the studies, as the info is pulled from the FDA antagonistic occasions database.
Final week, the replace got here because the FDA revised its scarcity record to observe that the .25 mg starter dose of semaglutide-based weight problems med Wegovy is now obtainable within the U.S.
Lower than a month in the past, the FDA eliminated Eli Lilly And Co’s LLY tirzepatide from its scarcity record.
Quickly after the scarcity was resolved, the FDA reminded compounders of the authorized restrictions on making copies of FDA-approved medicine. The replace has sparked concern amongst medical professionals, sufferers, and drug compounding services.
An organization spokesperson referred Reuters to the FDA’s database, which tracked these occasions over the previous two years. Adversarial occasion studies, that are submitted by medical doctors, sufferers, drugmakers, and others, are primarily used as an early warning system.
These studies will not be thought of conclusive proof of causality and infrequently lack vital particulars. Moreover, it’s attainable that a number of submissions might describe the identical incident.
Knudsen additionally mentioned the corporate’s ongoing efforts to handle security considerations associated to compounded variations of its medicine.
He talked about that Novo Nordisk has been monitoring the marketplace for compounded merchandise and has recognized a number of issues of safety.
Novo Nordisk argues that these compounded variations might pose security dangers, akin to impurities and incorrect dosages, and generally lack the lively ingredient totally.
On Wednesday, Novo Nordisk launched Q3 earnings. “Following higher-than-expected quantity progress lately, together with GLP-1-based merchandise akin to Ozempic and Wegovy, mixed with the expectation of continued quantity progress and capability limitations at some manufacturing websites, the outlook additionally displays anticipated continued periodic provide constraints and associated drug scarcity notifications throughout a variety of merchandise and geographies,” it added.
Worth Motion: NVO inventory is up 1.59% at $107.04 on the final examine on Thursday.
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