As Omicron rages, FDA clears new Eli Lilly/AbCellera antibody days after $720M supply deal – Endpoints News

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The FDA has cleared a new Covid-19 antibody from Eli Lilly and AbCellera, adding a much-needed weapon to the arsenal against Omicron.

Just days ago, the two companies unveiled a $720 million deal to supply 600,000 doses of the drug, bebtelovimab, to the US government. It can now be prescribed, under emergency use authorization, to adults and adolescents 12 years of age or older who test positive for SARS-CoV-2 and who are either at high risk of disease progression severe or unable/ineligible for other treatment options.

“At the start of the COVID-19 pandemic, we and our partners prioritized speed in delivering therapies to patients. This culminated in the discovery of bamlanivimab, the first COVID-19 antibody to reach the clinic and receive emergency use authorization from the FDA,” AbCellera CEO Carl Hansen said in a statement. declaration. “We then shifted our focus to finding a next-generation therapeutic antibody, this time prioritizing maximum potency and breadth of neutralization. This led to the discovery of bebtelovimab, which neutralizes all known variants of concern, and is the most potent antibody in development against the Omicron variant, including BA.2.

While bamlanivimab – used in combination with Eli Lilly’s other antibody etesevimab (in partnership with Junshi) – played a role in earlier waves, it brought little to the table when Omicron became the dominant variant. The United States stopped shipping them, along with Regeneron’s antibody cocktail, in late January.

Daniel Skovronski

The only mAb currently available in the US to treat Covid-19 is sotrovimab from GlaxoSmithKline and Vir, but supply is limited. States and jurisdictions receive approximately 50,000 doses per week; the seven-day average number of reported cases currently sits just north of 172,000.

Discovered by AbCellera and developed by Lilly, bebtelovimab has been in the pipeline since early 2021, according to Daniel Skovronsky, Lilly’s chief scientific and medical officer. Unlike previous antibodies that were cleared on phase III data, tt was tested in a phase II trial, dubbed BLAZE-4, which enrolled low-risk and high-risk patients.

Patrizia Cavazzoni

The way the trial was designed, the placebo-controlled part recruited 308 low-risk patients, where treatment reduced the time to sustained resolution of symptoms. In another part that also recruited high-risk patients, only bebtelovimab and combinations of bebtelovimab with other antibodies were given, and investigators reported that monotherapy and combinations reduced hospitalization and death rates related to Covid-19 compared to previously reported placebo rates. testing – a metric that regulators recognized could only lead to limited conclusions.

Detailed data, however, has not yet been released.

Still, CDER Director Patrizia Cavazzoni points out that activity against Omicron in addition to all other variants of interest (as demonstrated with lab data) is essential “at a time when we seek to further increase the offer”.

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