US buys Lilly COVID antibody, as effectiveness questions remain

The US government said it will buy 300,000 doses of Eli Lilly’s COVID-19 therapy bamlanivimab for $375 million if the drug gets Emergency Use Authorisation (EUA) – although its effectiveness has been called into question.

The initial agreement is for delivery over the two months following an EUA, and provides the option for the government to purchase up to an additional 650,000 vials through 30 June 2021.

Lilly filed for emergency use authorisation (EUA) of bamlanivimab for the treatment of recently diagnosed mild to moderate COVID-19 illness in high-risk patients in early October.

The US has said that patients will have no out-of-pocket costs for the medicine – echoing a promise by Lilly CEO Dave Ricks – although healthcare facilities may charge a fee for the product’s administration. 

The federal government, in partnership with state health departments, is developing a government allocation program for bamlanivimab.

Ricks has said that the company “must work with global health systems to ensure equitable access to our medicine at a fair price”.

“Our goal is to ensure that Lilly antibody treatments are available to patients who need them, no matter where they live.

“As long as supply of neutralising antibodies is constrained, we believe the only way to ensure equitable access is for Lilly to contract directly with governments and pan-national philanthropic organisations. These institutions are best positioned to direct our antibody treatments to the patients who need them most.”

He added that treatment allocation will be based on unmet medical needs globally and that  equitable government pricing will be tiered based on a country’s ability to pay.

But the news might be dampened somewhat by this week’s announcement that no more patients will be treated with bamlanivimab in a trial run by the National Institute of Allergy and Infectious Diseases (NIAID), as results to date suggest it is unlikely to be effective.

The ACTIV-3 study was comparing bamlanivimab (also known as LY-CoV555 or LY3819253) and placebo when added to therapy with Gilead Sciences’ Veklury (remdesivir), which is already approved to treat COVID-19 requiring hospitalisation.

According to Lilly, the NIAID took its decision on the strength of trial data  which indicated that bamlanivimab – an antibody that neutralises the SARS-CoV-2 coronavirus – was unlikely to help hospitalised patients recover from advanced-stage COVID-19.

The drugmaker stressed however that other trials of its drug in COVID-19 are still continuing, and it pointed out that the earlier BLAZE-1 study of bamlanivimab showed a reduced rate of hospitalisation in patients treated with the antibody in the outpatient setting.

It also said it “remains confident…that bamlanivimab monotherapy may prevent progression of disease for those earlier in the course of COVID-19.

ACTIV-3 is a substudy of a larger, 10,000-patient trial that is putting a series of COVID-19 drugs through their paces, and Lilly’s drug is the only arm to include an antibody targeting SARS-CoV-2. In each case, 300 patients are enrolled initially before a decision is taken whether to expand the trial to 1,000 subjects.

In a statement, the NIAID said enrolment of patients into the bamlanivimab was paused on 13 October after 326 had been recruited, “out of an abundance of caution”, and terminated on 26 October.

There were no safety issues – the decision was “driven by lack of clinical benefit for LY-CoV555,” according to the agency – and the patients will continue to be followed for 90 days’ follow-up.

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

BLAZE-1 is also continuing – looking at bamlanivimab alone and in combination with etesevimab (LY-CoV016) another Lilly antibody targeting SARS-CoV-2 – and the company is also running the BLAZE-2 trial of bamlanivimab as prophylaxis against COVID-19 in nursing home residents and staff.

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