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FDA clears Lilly’s COVID-19 antibody cocktail for emergency use

Dive Brief:

  • The Food and Drug Administration on Tuesday cleared an antibody drug cocktail from Eli Lilly for emergency use for treating people recently diagnosed with COVID-19, giving doctors another medicine to help keep their patients out of the hospital.

 

  • The cocktail, a combination of two coronavirus-targeting antibodies, is authorized only for people with mild or moderate symptoms of COVID-19, but who are at high risk of the disease’s worst effects due to age, underlying medical conditions or other preexisting conditions.

 

  • In a late-stage study of 1,035 patients, treatment with Lilly’s drug sharply reduced the risk of hospitalization and dying by 70% compared to a placebo. No participants in the trial who were given the cocktail died from COVID-19.

 

Dive Insight:

The case for COVID-19 antibody drugs has been strengthened in recent weeks by new data indicating treatment can both help to prevent disease as well as cut the risk of the worsening symptoms. Tuesday’s authorization of Lilly’s combination treatment adds another option, one that could be particularly useful as fast-spreading virus variants raise new concerns.

The combination pairs Lilly’s bamlanivimab, which the FDA authorized for emergency use in November, with another antibody called etesevimab that the drugmaker developed in partnership with China’s Junshi Biosciences. Each antibody targets a separate section of the “spike” protein used by the SARS-CoV-2 virus to breach the body’s cells — a feature designed to preserve the drug’s effectiveness even as the virus mutates.

Regeneron, which won FDA authorization for its antibody treatment a few weeks after Lilly did, also uses two antibodies together for the same reason.

Both developers are taking seriously the threat of reduced drug effectiveness against coronavirus variants like the ones that developed in the U.K., South Africa and Brazil. Recent data from laboratory testssuggested Lilly’s bamlanivimab, used on its own, may be ineffective against the variant from South Africa, while the potency of one component of Regeneron’s combination was weakened.

In late January, Lilly announced a partnership with Vir Biotechnology and GlaxoSmithKline to test a new antibody drug combination for use against “current and future strains of COVID-19.”

To date, antibody drugs haven’t been widely utilized, hamstrung by the logistical difficulties of giving an infused treatment to newly diagnosed COVID-19 patients, before their symptoms start to worsen. Hospitals, for example, have struggled to find the staff and space to bring in and treat people infected with SARS-CoV-2, while minimizing the risk of further contagion.

And, until now, the data supporting the use of Lilly’s and Regeneron’s drugs was relatively modest, and limited to certain subgroups of people at higher risk, or whose immune systems aren’t combating infection.

New results for Lilly’s combination and for Regeneron’s treatment, however, indicate the drugs can be used to protect people in nursing homes or living with an infected person from contracting COVID-19. Data from another study, meanwhile, showed treatment with Lilly’s combination significantly reduced hospitalization and death in people with mild or moderate symptoms.

That latter data supported the FDA’s new authorization, which is restricted to people over the age of 12 and who are within 10 days of their symptoms beginning.

The agency cleared a lower dose than the one Lilly tested in its study, noting that data on virus levels and drug metabolization indicated the effects would be similar.

A lower dose could allow Lilly to stretch its supplies of the drug cocktail further. In a Feb. 9 statement, Lilly said it anticipates producing 1 million doses of etesevimab by mid-2021. One hundred thousand are available for immediate use together with bamlanivimab, according to the company.

The antibodies are infused together in a procedure that can be completed in as little as 21 minutes. Previously, the FDA had specified that infusions should be done over 60 minutes, which limited the number of patients a hospital or clinic could treat in one day.

Data from the federal government show that some 532,000 doses of bamlanivimab have been distributed to state health authorities in the U.S.