Eli Lilly LLY initiated the final step in its planned transition to treat non-hospitalized COVID-19 patients only with the combination of its two COVID-19 antibody candidates,bamlanivimab (LY-CoV555) plus etesevimab (LY-CoV016). As part of the plan, the company announced that it has requested the FDA to revoke the emergency use authorization (“EUA”) granted to bamlanivimab alone for the treatment of patients at high risk for progressing to severe COVID-19 illness or hospitalization last year.

The company decided to stop administration of bamlanivimab alone as the combination regimen has been observed to neutralize more of the emerging COVID-19 variants like the UK (B.1.1.7.) variant in the United States compared to bamlanivimab alone. A treatment with the two antibody candidates together also seems more effective against the rapidly growing B.1.427/B.1.429 California strain.

Lilly informed that currently it is not putting similar withdrawal of authorization request in any other country. However, it stated that bamlanivimab plus etesevimab should be the preferred treatment regimen wherever the combination regimen has been authorized to use.The company also pointed out that existing bamlanivimab inventories at sites of care should not be disposed off. Instead, sites need to order etesevimab required to complete the combination regimen. The company last week also modified its purchase agreement with the U.S. governmentto enable the supply of etesevimab to complement doses of bamlanivimab the U.S. government has already purchased.

The company also stated that it will submit regulatory applications seeking approval/authorization for the combination regimen only going forward. Meanwhile, Lilly reported that in collaboration with Amgen AMGN,it will able to meet its global supply demand of bamlanivimab and etesevimab.

Bamlanivimab was a key driver of Lilly’s sales growth in the fourth quarter of 2020, contributing $871.2 million in sales due to a key supply contract with the U.S. government. Sales should be higher in 2021 with emergency approval received for bamlanivimab/etesevimab cocktail. In fact, in 2021, Lilly expects to generate revenues in the range of $1-$2 billion from COVID-19 therapies.

Shares of Lilly have rallied 12% so far this year compared with the industry’s increase of 1.7%.

Please note that data from a phase III study — BLAZE — demonstrated that bamlanivimab plus etesevimab significantly reduced COVID-19-related hospitalizations and deaths by 70% in high-risk patients having recently been diagnosed with COVID-19.The study also met all key secondary endpoints wherein bamlanivimab + etesevimab demonstrated high statistical significance, which proves that the therapy reduced viral load and accelerated symptom resolution.

Additionally, Lilly is exploring the lower doses of bamlanivimab and etesevimab together in the BLAZE-4 study. Per the company, initial results from this ongoing study provide viral load and pharmacodynamic/pharmacokinetic data, which showed that lower doses of bamlanivimab (700 mg) and etesevimab (1400 mg) together are similar to the authorized higher doses of bamlanivimab (2800 mg) and etesevimab (2800 mg) together.

Meanwhile, Lilly is also developing bamlanivimab in combination with Vir Biotechnology’s VIR antibody candidate, VIR-7831, for low-risk adult patients with mild-to-moderate COVID-19. Data from a mid-stage study demonstrated that the cocktail therapy achieved a 70% relative reduction in persistently high viral load after seven days of treatment compared to placebo.

Meanwhile, Lilly’s oral JAK inhibitor, Olumiant, has EUA for use in combination with Gilead’s GILD remdesivir to treat hospitalized COVID-19 patients.

Eli Lilly and Company Price

Eli Lilly and Company price | Eli Lilly and Company Quote

Zacks Rank

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