Eli Lilly receives FDA approval for its Alzheimer’s drug Kisunla

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on Jul 2, 2024
Updated: Jul 3, 2024
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  • FDA approved Eli Lilly's donanemab for Alzheimer's today.
  • Lilly will now compete directly with Biogen's Leqembi.
  • Eli Lilly stock is currently up more than 50% for the year.

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Eli Lilly & Co (NYSE: LLY) received approval for its Alzheimer’s drug from the Food & Drug Administration on Tuesday. 

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The development is significant as it expands treatment options for the neurological disorder that affects close to 7 million Americans. 

At the time of writing, Eli Lilly shares are exchanging hands at $910. The pharma stock has gained more than 50% since the start of 2024. 

Is Kisunla news significant for Eli Lilly stock?

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Alzheimer’s is among the top five causes of deaths for Americans aged more than 65. 

More importantly, the number of patients suffering from this mind-wasting disease is expected to hit 13 million in the United States by 2050, which underscores the urgent need for effective treatments like Lilly’s donanemab. 

Securing FDA approval for its Alzheimer’s drug is a major breakthrough for Eli Lilly. That’s because the U.S. regulator cited insufficient data as it rejected donanemab last year. The approval faced unexpected delay in March of 2024 as well. 

The Alzheimer’s news may unlock the next leg up in Eli Lilly stock that has outperformed this year on the back of strong demand for its weight-loss drug. 

Many expect LLY to be the first healthcare name to hit $1.0 trillion in valuation. 

Lilly to compete directly with Biogen

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FDA’s full approval for Lilly’s Alzheimer’s drug arrives shortly after its advisory panel concluded the benefits of donanemab outweigh the risks. 

The $870 billion behemoth will now compete directly with Biogen that secured approval for Leqembi (its Alzheimer’s drug) in summer of 2023. Donanemab is set to become the third treatment for Alzheimer’s to hit the market in the U.S. 

Both Leqembi and Donanemab are monoclonal antibodies that target amyloid plaques. Neither is a definitive cure and both can have potential safety concerns including brain swelling and bleeding that can sometimes be fatal. 

Three patients, for example, in the late-stage study of Eli Lilly died due to ARIA (amyloid-related imaging abnormalities). 

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Note that Eli Lilly will market its Alzheimer’s drug as “Kisunla”. In June, former FDA commissioner Dr Scott Gottlieb said Alzheimer’s could be a very big category for LLY.

The donanemab news arrives a couple weeks after the New York listed firm announced $1.30 a share of dividend for the third quarter. 

It also teamed up with OpenAI last month to tap on artificial intelligence to discover novel medicines and treat drug-resistant bacteria. Brad Lightcap – the chief operating officer of LLY said at the time:

Advanced AI has the potential to deliver innovative breakthroughs in pharma, and we’re committed to working together with industry leaders to deliver tangible benefits for patients.

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