0209 LLY EUA
BioCentury & Getty Images

Regulation

Lilly mAb combo gains EUA with shortened infusion time

Feb 10, 2021 | 2:34 AM GMT

An EUA for Lilly’s mAb cocktail to treat mild-to-moderate COVID-19 outpatients aged 12 and older comes with a shortened infusion time that could ease administration. 

FDA granted emergency use authorization to the combination of bamlanivimab and etesevimab with an infusion time of 21 minutes, and shortened the authorized infusion time for bamlanivimab monotherapy from 60 minutes to 16 minutes. 

In clinical trials, the combination therapy led to more robust changes in viral load reduction than bamlanivimab alone. 

Eli Lilly and Co. (NYSE:LLY), in collaboration with Amgen Inc. (NASDAQ:AMGN), plans to manufacture up to one million doses of etesevimab by mid-2021 to administer with bamlanivimab. Lilly developed etesevimab with partner Shanghai Junshi Biosciences Co. Ltd. (HKEX:1877; Shanghai:688180). 

Banlanivimab, which Lilly developed with AbCellera Biologics Inc. (NASDAQ:ABCL), is already authorized to treat outpatients with mild-to-moderate disease, but logistical barriers around IV infusion have limited its use. Many infusion sites are at hospitals whose resources are already stretched by treating more advanced COVID-19 patients. Adding care of outpatients not only further stretches resources, it risks exposure of non-COVID patients receiving infusions, including high-risk groups such as cancer patients.

A shortened infusion window should somewhat ease the strain on resources, though it won’t solve the latter problem.

Last month, the pharma announced plans to test a subcutaneous injection of its mAb cocktail in a third arm of its Phase III BLAZE-1 study to treat mild-to-moderate COVID-19 in high-risk outpatients. The administration route would make trips to infusion centers unnecessary. 

An open question is how the emerging SARS-CoV-2 variants will affect Lilly’s mAbs. Preclinical data so far suggest the mAbs are likely to lose efficacy.

Lilly is collaborating with Vir Biotechnology Inc. (NASDAQ:VIR) and GlaxoSmithKline plc (LSE:GSK; NYSE:GSK) to combine bamlanivimab with VIR-7821 to address emerging variants. The cocktail is under evaluation in the Phase II BLAZE-4 study to treat low-risk COVID-19 outpatients; data could read out as early as 1H21. 

How to gain access

Continue reading with a
two-week free trial.