US pulls authorisation for bamlanivimab monotherapy in COVID-19

The FDA said Friday that it granted a request by Eli Lilly to revoke the emergency-use authorisation (EUA) for use of its COVID-19 antibody therapy bamlanivimab alone. The company made the request based on an "evolving variant landscape" in the US, and not because of any new safety concern, adding the move is the final step towards switching to only supplying bamlanivimab as part of an antibody cocktail co-administered with etesevimab.

According to Lilly, the antibody cocktail can "neutralise more" emerging COVID-19 variants in the US than bamlanivimab alone, including the closely related B.1.427 and B.1.429 strains that currently account for 50% of the virus in California and over 10% across some other states. "With the growing prevalence of variants in the US that bamlanivimab alone may not fully neutralise, and with sufficient supply of etesevimab, we believe now is the right time to complete our planned transition and focus on the administration of these two neutralising antibodies together," remarked chief scientific officer Daniel Skovronsky.

Revised US supply pact

The move comes after Lilly recently revised its contracts with the US to enable the supply of etesevimab to complement doses of bamlanivimab that the federal government had already bought. The amended contract terminates the purchase agreement for bamlanivimab alone and cancels the remaining roughly 351,000 doses that were scheduled to be delivered by the end of March.

Bamlanivimab was granted an EUA in November to treat mild-to-moderate COVID-19 in recently diagnosed patients at risk for progressing to worse disease, generating sales of $871.2 million in the fourth quarter of 2020, mostly in the US. However, late last month, the US stopped distributing bamlanivimab monotherapy, citing a "sustained increase" in SARS-CoV-2 variants that showed resistance to treatment when administered alone. The EUA for bamlanivimab given together with etesevimab was issued this past February.

Not seeking withdrawal elsewhere, but combo 'preferred'

Lilly noted that bamlanivimab alone and/or co-administered with etesevimab are authorised under special pathways in 20 countries outside the US, with both retaining "neutralisation effects against the vast majority of variants," including B.1.1.7. At the moment, the company said it is not asking other regulatory bodies to withdraw emergency authorisations for bamlanivimab alone, but its use with etesevimab "is preferred."

Together with its manufacturing partner Amgen, the drugmaker indicated that it expects to produce sufficient amounts of bamlanivimab and etesevimab to meet global supply needs, and going forward, it intends to submit only the dual antibody cocktail for authorisation globally, with a full transition expected by June. Meanwhile, Lilly said it plans to keep developing complementary neutralising antibodies to address potential SARS-CoV-2 variants that may arise in the future.

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