Shocking Battle: Why the Maker of ‘Magic’ Weight-Loss Drug Semaglutide Fights to Ban Copycats
Novo Nordisk, the Danish pharmaceutical company behind the weight-loss drug Wegovy and diabetes medication Ozempic, has urged the US authorities to halt the compounding of these drugs, citing serious safety concerns. Compounding involves licensed pharmacists or physicians modifying or combining medication ingredients to meet patient needs, especially when branded versions are scarce. Due to high demand, US pharmacies have been producing compounded versions of these drugs, which contain semaglutide.
Novo Nordisk has expressed concerns over the safety of these compounded versions and has taken legal action against clinics and pharmacies, citing reports of at least 10 deaths and over 100 hospitalizations from compounded products. In response, the company has filed a request with the US FDA to list semaglutide on the Demonstrable Difficulties for Compounding (DDC) list, which restricts compounding when commercial versions are available.
Novo Nordisk highlights key issues with compounded semaglutide:
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Complex Formulation: The drug’s intricate structure, created with recombinant DNA technology, is hard to replicate accurately, potentially affecting purity and effectiveness.
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Delivery Mechanism: The FDA-approved version uses advanced delivery methods, such as single-use pen injectors, ensuring correct dosage and safety. Compounded versions may lack such precision, raising the risk of dosing errors.
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Bioavailability: Semaglutide’s naturally low bioavailability means compounded versions may not be absorbed properly, compromising treatment efficacy.
- Contamination and Stability Risks: Compounding requires specialized equipment to prevent contamination. Additionally, semaglutide is temperature-sensitive, and improper storage can affect its stability.
Novo Nordisk’s appeal comes as it emphasizes patient safety concerns amid growing reports of adverse effects linked to compounded semaglutide. The FDA has yet to rule on this request, as similar challenges by competitor Eli Lilly also remain unresolved.
Original Story https://indianexpress.com/article/explained/explained-health/why-maker-of-magic-weight-loss-drug-semaglutide-wants-copies-banned-9668561/
Category : Explained,Explained Health
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Publish Date: 2024-11-14 06:00:00
