© Reuters. File photo: March 5, 2021, at the Eli Lilly and Company pharmaceutical plant at 50 ImClone Drive, Blanche, New Jersey. REUTERS/Mike Segar
Authors: Manas Mishra and Carl O’Donnell
(Reuters)-Eli Lilly said on Tuesday that it plans to seek U.S. approval for its experimental Alzheimer’s disease drug by the end of the year, and believes that the therapy will be favored by doctors once it is available to patients.
Eli Lilly (NYSE:) shares rise 4%
Biogen’s (NASDAQ:) Alzheimer’s drug received a landmark U.S. approval in June, which increases the chances of other drugs to clear brain plaque. Several companies, including Eli Lilly, have been hoping to bring similar drugs to the market.
Eli Lilly said it plans to submit interim data on donamizumab to regulators that the drug is more effective in removing beta amyloid brain plaque than any other treatment.
“If you think lowering amyloid plaques is a good thing, then you will want the drug that can best reduce amyloid plaques,” Chief Scientific Officer Daniel Skovronsky told investors during a conference call discussing quarterly results.
“There will be some doctors, I believe the same is true today, they still say that I don’t want to use drugs until I have cognitive data,” Skovronsky added.
The U.S. Food and Drug Administration has been severely criticized for approving Biogen drugs without definite evidence of patient benefit and opposition from its external panel of experts.
Eli Lilly said it is conducting a phase III trial to prove that the drug also helps to slow down the cognitive decline of patients, and it is expected that the study will be completed in 2023.
The FDA approved Biogen’s Aduhelm on June 7 using its accelerated approval pathway, which requires a study to confirm that the drug is effective against the deadly mental wasting disease that affects millions of Americans.
Although the FDA’s nod was initially welcomed by patient associations and long-awaited doctors, Congress is now investigating the controversial approval process and the agency’s relationship with Biogen.
In the second quarter, Lilly’s profit was lower than analysts expected because of sluggish demand for its COVID-19 antibody drug, and the introduction of the US vaccine has weakened demand for the drug.
U.S. regulators stopped the distribution of this treatment in late June because of its low effectiveness against some highly infectious coronavirus variants that have emerged.
According to Refinitiv IBES data, excluding items, Eli Lilly’s earnings per share were US$1.87, 2 cents lower than Wall Street’s expectations
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