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Eli Lilly’s (NYSE:LLY) COVID-19 Therapy Loses FDA Authorization

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The U.S. Food and Drug Administration has currently pulled the emergency use authorization for Eli Lilly’s COVID-19 drug bebtelovimab because it is not expected to neutralize Omicron subvariants BQ.1 and BQ.1.1.

The U.S. Food and Drug Administration (FDA) has currently pulled back the emergency use authorization (EUA) for healthcare giant Eli Lilly’s (NYSE:LLY) COVID-19 drug bebtelovimab as it is not expected to be effective against two Omicron subvariants (BQ.1 and BQ.1.1.). These two subvariants are now dominant in the U.S. and accounted for over 57% of the COVID-19 cases in the country, per government data published last week.

Eli Lilly and its authorized distributors have halted the commercial distribution of bebtelovimab until further notice by the FDA. Furthermore, the FDA has advised heathcare providers to retain and properly store any unused bebtelovimab in case other COVID-19 variants that are susceptible to the drug become dominant in the future. Eli Lilly’s monoclonal antibody bebtelovimab won the FDA’s EUA for the treatment of mild-to-moderate COVID-19 in February this year.

Healthcare providers can use Pfizer’s (PFE) Paxlovid, Merck’s (MRK) Lagevrio, and Gilead Sciences’ (GILD) Veklury as treatments against BQ.1 and BQ.1.1 subvariants. Additionally, COVID-19 convalescent plasma can be used for the treatment of COVID-19 in patients with immunosuppressive disease or receiving immunosuppressive treatment.

Separately, Eli Lilly and Biogen (BIIB) have been in the news due to their Alzheimer drug candidates. On Wednesday, Japanese firm Eisai Co. (ESALY), which is co-developing Alzheimer drug lecanemab with Biogen, presented full findings from the Phase 3 Trial of the drug at the Clinical Trials on Alzheimer’s Disease (CTAD) conference held in San Francisco. Eli Lilly also presented positive data related to its Alzheimer drug donanemab at the CTAD conference.

The approval of these drugs could fetch billions of dollars for these companies. Nonetheless, regulatory authorities will take into account concerns about the side effects of these drugs, including brain swelling and bleeding.

Is Eli Lilly a Buy, Sell, or Hold?

Eli Lilly stock has advanced 34.3% so far this year. Wall Street’s Strong Buy consensus rating for Eli Lilly is based on 12 Buys and two Holds. The average LLY stock price target of $383.69 suggests a modest upside potential of 3.4%.

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