Eli Lilly LLY is intensifying its efforts to combat imitation versions of its popular appetite-suppressing drugs, Mounjaro and Zepbound.
What Happened: The pharmaceutical giant is seeking to end a regulatory designation that has permitted cheaper, off-brand versions to thrive. Lawyers for Eli Lilly have notified healthcare providers that shortages of Mounjaro and Zepbound are effectively over, despite the FDA not yet confirming this status, reported The Washington Post.
On Tuesday, Eli Lilly launched a discounted product, presenting it as a safer alternative to the off-brand medications. This move comes as the company faces competition from compounding pharmacies that have been making copies of its top-selling diabetes and weight-loss drugs since 2022.
The FDA placed the active ingredients in Mounjaro and Zepbound on its shortage list, allowing specialized pharmacies to create their own versions. Eli Lilly has been working to boost its supplies and claims that its drugs are now “commercially available.”
However, only the FDA can officially determine when a shortage is resolved. The agency is currently evaluating whether the supply of tirzepatide, the active ingredient, meets their criteria for a resolved shortage.
Meanwhile, Eli Lilly continues to advocate for patient safety, urging the FDA to remove the shortage designation and warning against the use of compounded versions of its drugs, according to the report.
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Why It Matters: The battle over weight-loss drugs is heating up as Eli Lilly faces increasing competition from compounding pharmacies. The company has been proactive in addressing the issue by launching cheaper versions of its own drugs.
On Tuesday, Eli Lilly released low-dose vials of Zepbound, priced up to 50% lower, to enhance accessibility and meet the high demand for its weight-loss medication. This move aims to counter the proliferation of off-brand versions and ensure patient safety.
Adding to the competitive landscape, Novo Nordisk NVO recently published promising data on its weight-loss drug Wegovy, showing a 31% reduction in the risk of cardiovascular death or worsening heart failure events. This development underscores the intense rivalry in the weight-loss drug market, as companies strive to demonstrate the efficacy and safety of their products.
Furthermore, Eli Lilly has been compared to NVIDIA Corp in the weight-loss and GLP-1 space by Roundhill Investments CEO Dave Mazza. He emphasized the company’s market leadership and growth potential, attributing its success to the high demand and limited supply of its drugs.
In addition to its weight-loss drugs, Eli Lilly is also navigating challenges in other areas. The company’s Alzheimer’s drug, donanemab, faces potential rejection by the U.K.’s National Health Service due to safety concerns and high costs. This situation underscores the broader regulatory and market challenges that pharmaceutical companies must navigate.
Price Action: Eli Lilly and Co closed at $960.02 on Friday, marking a gain of 2.11% for the day. After hours, the stock saw a slight dip of 0.0021%. Year-to-date, Eli Lilly’s stock has surged 62.11%, according to data from Benzinga Pro.
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This story was generated using Benzinga Neuro and edited by Kaustubh Bagalkote
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
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