Eli Lilly Receives Emergency Use Nod for COVID-19 Antibody Therapy in Patients Under Age 12

Eli Lilly and Company’s (LLY) antibody treatment has received expanded Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) to include certain high-risk pediatric patients under the age of 12.

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This expansion authorizes the pharmaceutical company’s bamlanivimab with etesevimab as the first-of-its-kind neutralizing antibody therapy to be administered together in high-risk pediatric patients for the treatment of mild to moderate COVID-19 and post-exposure prophylaxis (PEP).

Supporting Data

The U.S. regulator’s decision was based on the safety and efficacy clinical data from pediatric and infant patients in BLAZE-1, a phase 2/3 trial, which was designed to study bamlanivimab and etesevimab administered together for the treatment of mild to moderate COVID-19, and who are at high risk of severe disease progression. This data shows that the therapy retains neutralization activity against the Delta variant, and the company is working hard to understand the neutralization activity on the Omicron variant. (See Eli Lilly stock charts on TipRanks)

To date, more than 700,000 patients have been treated with bamlanivimab, or a combination of bamlanivimab and etesevimab. Additionally, it potentially prevented more than 35,000 hospitalizations and a minimum of 14,000 potential deaths during the worst of the pandemic.

Official Comments

Eli Lilly’s CMO Daniel Skovronsky said, “Our mission since the start of the pandemic has been to offer crucial support by developing therapeutic options that could prevent hospitalization and death for as many people as possible.”

“With the FDA’s decision to allow the use of bamlanivimab with etesevimab in children and infants, Lilly can now offer treatment and prevention options to high-risk individuals of any age,” Skovronsky added.

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Analysts Recommendation

On November 29, UBS analyst Navin Jacob reiterated a Hold rating on the stock but increased the price target to $267 (8.72% upside potential) from $193.

The consensus rating among analysts is a Strong Buy based on 7 Buys and 1 Hold. The average Eli Lilly price target stands at $281.50 and implies upside potential of 14.63% to current levels. Shares have gained more than 66% over the past year.

Investors

TipRanks’ Stock Investors tool shows that investors currently have a Very Positive stance on Eli Lilly, with 2.8% of investors maintaining portfolios on TipRanks increasing their exposure to LLY stock over the past 7 days.