COVID-19: FDA Grants Emergency Use Authorization for Eli Lilly’s Antibody Combo Therapy

On February 9th, Eli Lilly announced receiving the FDA’s emergency use authorization for its COVID-19 combination therapy comprising bamlanivimab and etesevimab. The approval was based on data from the Phase 3 BLAZE1 trial, the results of which were announced in late January. The authorization adds to the growing number of EUA approved treatments for COVID-19 in the past months.

“Lilly has dedicated our time, resources, and expertise to discover and develop therapies to treat COVID-19. Bamlanivimab alone under emergency use authorization has already provided many people with an early treatment option that could prevent hospitalizations, and we are excited to now add an additional therapeutic option with a similar demonstrated clinical benefit,” said Dr. Daniel Skovronsky, Chief Scientific Officer and President of Lilly Research Laboratories.

“Additionally, with the risk of resistance emerging as various strains of the virus arise, bamlanivimab and etesevimab together could potentially allow efficacy against a broader range of naturally occurring SARS-CoV-2 variants as these new strains spread around the world”.

BLAZE-1

BLAZE-1 is a double-blinded, randomized Phase 2/3 clinical trial that tested the efficacy and safety of bamlanivimab alone and the combination of bamlanivimab and etesevimab in patients with symptomatic COVID-19.

The Phase 3 arm of this trial focussed on testing the efficacy of the combination therapy compared to placebo in patients at high risk of progressing to severe COVID-19. The primary endpoint was the percentage of patients who experienced COVID-19 related deaths or hospitalization. The combination therapy reduced the COVID-19 related hospitalization by 70% compared to placebo.

This ongoing trial is expected to enroll more than 3000 patients. Further, another clinical trial, BLAZE-4, is currently testing the combination therapy’s efficacy at several lower doses. The preliminary data is encouraging, where a lower dose has shown a similar response in patients.

Challenges Ahead

With bamlanivimab receiving approval last year for COVID-19 treatment, Lilly had huge expectations from the drug. However, bamlanivimab has had a disappointing start mainly due to logistics issues. One of the major problems faced is, the drug has to be infused in a hospital setting, and the infusion time was previously 60 minutes.

The current emergency use approval reduced the infusion time from 60 minutes to 21 minutes for combination therapy. Further, to help with the infusion process, Lilly has set up infusion centers across Indiana in partnership with the local health system. Additionally, Lilly is partnering with GSK/Vir to develop more combination therapies that they believe will have higher efficacy against the strains identified in Britain and South Africa.

Lily’s major competition comes from another antibody treatment from Regeneron. Regeneron’s cocktail antibody therapy is thought to be effective against the mutant strains, but this treatment also needs to be infused and has also encountered similar logistics issues. Joining the race is AstraZeneca, with their current research focussing on developing antibody treatment for COVID-19 patients. With Lilly aggressively trying to capture the market through partnerships with health care systems and other pharmaceutical giants, it will be interesting to see if the other competitors can keep up with it.

Related Article: South Africa Defers AstraZeneca Vaccinations as Vaccine Only Provides Minimal Protection against COVID-19 Variant

References

1. https://investor.lilly.com/news-releases/news-release-details/lillys-bamlanivimab-ly-cov555-administered-etesevimab-ly-cov016
2. https://investor.lilly.com/news-releases/news-release-details/lilly-vir-biotechnology-and-gsk-announce-first-patient-dosed
3. https://www.geneonline.com/lilly-teams-up-with-gsk-vir-to-fight-new-covid-19-variants-using-antibody-combo/

Author

Tulip Chakraborty