Lilly to ship COVID-19 drug straight away after FDA green light

Eli Lilly has said it will start shipping supplies of its COVID-19 drug bamlanivimab immediately, after claiming emergency-use authorisation (EUA) for the antibody.

The AbCellera-partnered drug, previously known as LY-CoV555 or LY3819253, can be used to treat mild-to-moderate COVID-19 in patients 12 years and older, who are at high risk for progressing to severe disease that might require hospitalisation.

President Trump has previously pledged to make antibody drugs available for free to anyone who needs them, and his administration has already signed a $375 million contract with Lilly to supply 300,000 doses of the drug within two weeks of the EUA.

The US has also taken an option on another 650,000 doses of the drug between now and the end of June 2021.

Lilly chief executive David Ricks has also said that patients should have no out-of-pocket costs for the drug, although healthcare facilities may charge a fee for the antibody’s intravenous administration.

The EUA as well as the US government contract came despite the results of the ACTIV-3 trial run by the National Institute of Allergy and Infectious Diseases (NIAID), which halted enrolment in the bamlanivimab arm because data to date suggested the drug was unlikely to be effective in hospitalised patients.

The FDA approved a 700mg single IV dose of the drug based on the phase 2 BLAZE-1 trial, which showed a reduced rate of hospitalisation in patients at high risk of COVID-19 progression who were treated with the antibody in the outpatient setting.

The NIAID is also running another study of Lilly’s antibody, ACTIV-2, which involves outpatients with mild-to-moderate COVID-19 symptoms.

Lilly says it will ship supplies of the drug to AmerisourceBergen, which will handle distribution once a week in accordance with the US government’s allocation plans. Where the drug is distributed will depend on confirmed COVID-19 cases across the US over the prior seven days.

Bamlanivimab – an antibody that neutralises the SARS-CoV-2 coronavirus – joins Gilead’s antiviral Veklury (remdesivir) on the list of drugs with EUAs for COVID-19, but is the first to be cleared for use outside hospitals.

Veklury’s EUA and subsequent full approval by the FDA covers the treatment of patients with COVID-19 who already require hospitalisation. The FDA has also issued EUAs for convalescent plasma for hospitalised patients, as well as for certain drugs that don’t target the virus directly but are used to support patients whilst in acute care.

Lilly notes that bamlanivimab should be administered as soon as possible after a positive COVID-19 test and within 10 days of symptom onset.

The company says it hopes to be able to produce up to one million doses of bamlanivimab 700mg by the end of 2020, “for use around the world through early next year.”

The FDA is meanwhile reviewing an EUA for Regeneron’s COVID-19 antibody therapy REGN-COV2, focusing on patients with mild to moderate disease who are at risk of progressing, and a decision on that could be made shortly.

REGN-COV2 also seems at risk of falling short in hospitalised patients, after a safety concern led to the pause of enrolment in a clinical trial in this setting earlier this month.

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