The US Food and Drug Administration has given Eli Lilly the first emergency use authorisation for a Covid-19 antibody treatment, which the drugmaker hopes will help vulnerable people avoid hospitalisation.
Eli Lilly’s bamlanivimab therapy has been authorised for mild-to-moderate patients, who are at risk for developing a more serious condition, such as the elderly, or those with chronic illnesses.
The treatment — designed to boost the immune system of patients with artificially engineered antibodies — is the first drug developed for use this early in the disease.
David Ricks, Eli Lilly’s chief executive, said it was a “valuable tool for doctors fighting the now-increasing burden of this global pandemic”.
Eli Lilly’s shares rose 3.1 per cent to $146.75 in after-hours trading in New York.
The emergency approval comes on the same day as a big breakthrough in a race for a vaccine. Pfizer and its German partner BioNTech announced their vaccine was far more effective than expected, with 90 per cent efficacy at an interim analysis of its phase 3 data.
Eli Lilly’s competitor Regeneron has also applied for an emergency use authorisation for its antibody treatment, which President Donald Trump took while sick and hailed as a “cure”.
Regeneron has paused a trial in its more seriously ill Covid-19 patients after an independent monitoring board suggested there might be a “potential safety signal”, with risks outweighing benefits.
Eli Lilly abandoned its trial in the sicker patients.
The FDA said Eli Lilly’s emergency approval was not for people already in hospital, where no benefit was shown, warning it could be associated with “worse outcomes” if the patient is on high flows of oxygen.
More data will be required for full FDA approval. Patrizia Cavazzoni, acting director of the FDA’s Center for Drug Evaluation and Research, said: “We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available.”
The company said it was on course to make a million doses by the end of 2020, with more manufacturing capacity allowing it to expand production in 2021. It is in talks with regulators in other countries about approval.
The US government would allocate 300,000 doses to high-risk patients, with no out-of-pocket costs for the medication, Eli Lilly said in a release. The federal government would allocate supplies based on Covid-19 rates in different regions in the previous seven days.
The emergency use authorisation is based on a phase 2 study that found it reduced viral load, symptoms and hospitalisation in mild-to-moderate patients. About 3 per cent of participants taking the drug had to visit the emergency room or be admitted to hospital, compared to 10 per cent on placebo.
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