Eli Lilly has become the first drugmaker to have three Covid-19 treatments authorized for emergency use by the FDA, racking up an EUA for the use of its two-drug antibody cocktail to treat recently diagnosed patients with mild to moderate disease.
The regulatory clearance comes just two weeks after Lilly released a large batch of data from the BLAZE-1 trial showing that the combo of bamlanivimab and etesevimab reduced deaths and hospitalizations by 70% among 1,000 patients. But it arrives much later than the pharma giant had hoped: As early as October, following initial results around viral load, ER visits and hospitalization rate, Lilly said it had applied for an EUA.
Bamlanivimab — which was co-developed by AbCellera — has already scored the first OK for an antibody treatment, although utilization has been much lower than expected.
One of the highlights of the new authorization, according to Lilly, is that regulators have signed off on shorter infusion times for both bamlanivimab alone and bamlanivimab plus etesevimab (which originally came from China’s Junshi). Patients can now wrap up infusions in 16 to 21 minutes, respectively, marking “a significant reduction from the previously authorized time of 60 minutes” and a lighter burden on nurses and doctors.
The authorized cocktail will comprise 700 mg bamlanivimab and 1,400 mg etesevimab.
“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,” CSO Dan Skovronsky said in a statement. “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.”
Amgen is lending Lilly a hand in manufacturing etesevimab, with plans to manufacture up to 1 million doses to pair with the same amount of bamlanivimab by mid-2021. Right now, 100,000 doses are ready to go — and 150,000 more should be available in the next month.
Josh Smiley — who’s just been ousted from the CFO post — has previously modeled the revenue from Covid-19 antibodies at a range of $1 billion to $2 billion based on that number, as well as around 500,000 doses of bamlanivimab for monotherapy.
“So if we sold all of that and it’s weighted heavily toward the US or high-income countries, you could get above $2 billion,” he told analysts in a recent call, adding: “If we get into the second half of the year, I think we can continue at the pace of production of million-plus doses available per quarter. I don’t think the manufacturing piece is going to be as much of a barrier in the second half of the year if we stay on the course of vaccines and otherwise.”
And Lilly isn’t done here.
Last month the company started testing a combination of bamlanivimab and GlaxoSmithKline/Vir’s drug candidate, and reported that bamlanivimab lowered nursing home residents’ and staff’s risk of contracting symptomatic Covid-19. It’s now exploring expanding the EUA for the antibody.
“We don’t see this as an alternative for a vaccine, but instead it could potentially be used for people who haven’t been vaccinated, and there’s an outbreak in their facility,” a spokesperson told Endpoints News at the time.
For SVB Leerink analyst Geoffrey Porges, there’s plenty of room for Lilly and rivals at Regeneron to push ahead.
“EUAs for the prophylactic setting (for both REGN and LLY) and for REGN’s subcutaneous dose could be real catalysts for mAb cocktail utilization, which so far has been mixed due to challenges in distribution, access to infusions, and physician adoption and education,” he wrote in a recent note.
Outside of antibodies, Lilly has an EUA for treating hospitalized patients with its JAK inhibitor Olumiant in combination with Gilead’s Veklury — a more severe indication that is still out of bounds for either bamlanivimab or etesevimab.
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