Eli Lilly Alzheimer's drug setback extends rival Biogen's lead

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The U.S. health regulator's rejection of accelerated approval for Eli Lilly and Co's Alzheimer's disease drug extends the market lead for rivals Eisai and Biogen's treatment by months, analysts said.

The U.S. Food and Drug Administration declined to approve donanemab's application because Lilly had not submitted data from enough patients who were treated for at least a year, the drugmaker"This is a modest positive for Biogen" because it delays donanemab's launch, Jefferies analyst Michael Yee said, adding that Eli Lilly could file for traditional approval by mid-2023.shares rose 1.5% to $284.5 in morning trade on Friday.

"Lilly's inability to launch donanemab near-term will prevent them from expediting their launch post-full approval by depriving them of the ability to begin to educate physicians and patients," said Citi analyst Andrew Baum.

 

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Thanks. I saw this a little while ago as big drama for some within biotech vertical geeks like me. I started laughing because it’s about an Eli Lilly US FDA submission & the logo is Biogen. I’m still skeptical about this “disease” as defined area as well as some safety signals.

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Eli Lilly Alzheimer's drug setback extends rival Biogen's lead - analystsThe U.S. health regulator's rejection of accelerated approval for Eli Lilly and Co's Alzheimer's disease drug extends the market lead for rivals Eisai and Biogen's treatment by months, analysts said.
Source: Reuters - 🏆 2. / 97 Read more »

FDA rejects Eli Lilly's proposed Alzheimer's treatment, says more data neededThe setback could delay a potential commercial introduction of the highly anticipated drug by at least several months, if the Food and Drug Administration... Don't get us started on big pharma concerns when it involves such a needed treatment respecting Alzheimer's people and their families. Safety and clinical trials no doubt are involved as the Covid business gushed with profits for stakeholder/shareholders? Yes, of course. Academic But it green-lighted the untested Covid vaccines...
Source: MarketWatch - 🏆 3. / 97 Read more »