Lilly (LLY) COVID-19 Antibody Combo Gets FDA's Emergency Nod

Eli Lilly & Company LLY announced that the FDA has granted Emergency Use Authorization (EUA) to a combination of its antibody drugs, bamlanivimab (700 mg) and etesevimab (1400 mg) for the treatment of mild-to-moderate COVID-19 in patients who are at high risk of progressing to severe COVID-19.

Bamlanivimab was granted EUA by the FDA in November 2020 as a monotherapy for high-risk patients recently diagnosed with mild-to-moderate COVID-19 based on data from the BLAZE-1 study. Bamlanivimab alone is now authorized for emergency/temporary use in numerous countries.

Along with the EUA, the FDA also authorized shortened infusion time for bamlanivimab alone as well as bamlanivimab/etesevimab combination, whose infusion time can now be 16 or 21 minutes, respectively, much less than the previously authorized time of 60 minutes.

The EUA was based on data from the phase III BLAZE-1 study, which showed that the bamlanivimab/etesevimab combination reduced risk of COVID-19 hospitalizations and death by 70% in high-risk patients recently diagnosed with COVID-19. These data were released last month.

Lilly, along with partner Amgen AMGN, plans to manufacture up to 1 million doses of etesevimab for use with bamlanivimab by mid-2021. Of these, 250,000 doses are expected to be manufactured this quarter. In September last year, Lilly signed a global manufacturing collaboration with Amgen to help manufacture its COVID-19 antibody therapies

So far this year, Lilly’s stock has risen 19.4% compared with an increase of 1.2% for the industry.

Meanwhile, other studies are ongoing on bamlanivimab in other patient populations and also in combination with etesevimab. Earlier this month, Lilly announced a deal with Vir Biotech VIR and Glaxo GSK to expand its ongoing BLAZE-4 study to evaluate bamlanivimab (700mg) with Vir Biotech/Glaxo’s investigational COVID-19 antibody, VIR-7831 (500mg) in low-risk patients with mild-to-moderate COVID-19. VIR-7831 is currently being evaluated in a phase II/III study for the early treatment of COVID-19 in adults at high risk of hospitalization.

Bamlanivimab was a key driver of Lilly’s sales growth in the fourth quarter, contributing $871.2 million in sales due to a key supply contract with the U.S. government. In fact, in 2021, Lilly expects to generate revenues in the range of $1-$2 billion from COVID-19 therapies.

In November, the FDA also granted EUA to Lilly and Incyte’s oral JAK inhibitor Olumiant for use in combination with Gilead’s remdesivir in hospitalized COVID-19 patients.

Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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