The US Food and Drug Administration (FDA) has granted emergency-use authorisation to drugmaker Eli Lilly (LLY) for its bamlanivimab therapy, a monoclonal antibody treatment. The treatment may be used on patients over the age of 12 with mild-to-moderate cases of COVID-19.
The treatment is similar to the one that outgoing US president Donald Trump received when he contracted coronavirus in October.
The antibody treatment works by boosting the immune system with engineered antibodies, and it is aimed at preventing at-risk patients developing more severe conditions due to COVID-19 — the FDA said it had approved the therapy for people who had not already been hospitalised due to the virus.
Eli Lilly’s chief executive David Ricks said it was a “valuable tool for doctors fighting the now-increasing burden of this global pandemic.” The company said it was planning to manufacture one million doses by the end of the year.
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Patrizia Cavazzoni, acting director of the FDA Center for Drug Evaluation and Research, said in a statement that the emergency-use approval "provides health care professionals on the frontline of this pandemic with another potential tool in treating Covid-19 patients."
“We will continue to evaluate new data on the safety and efficacy of bamlanivimab as they become available,” Cavazzoni said. The emergency-use approval is based on a Phase 2 study, and more data will be needed in order for the FDA to grant full approval.
Eli Lilly’s shares rose 3.1% to $146.75 in after-hours trading in New York.
The news of Eli Lilly’s drug approval came hot on the heels of the announcement from Germany’s BioNTech (BNTX) and its US partner Pfizer (PFE) that their mRNA vaccine candidate had been over 90% efficient at preventing COVID-19, based on early data from their Phase 3 trials of over 43,000 volunteers.
“Today is a great day for science and humanity,“ said Dr Albert Bourla, chairman and CEO of Pfizer in a statement.
Governments across the world are scrambling to make a plan for how they will begin to vaccinate their populations, in terms of prioritising certain groups such as the elderly and medics, as well as the daunting logistics of the operation.
While vaccination will likely be voluntary, a certain threshold of the population needs to be vaccinated for immunity to be prevalent.
British scientists said on Tuesday that 80% of the population would need to receive the vaccine to make it effective in communities.
However, a report by the British Academy and the Royal Society found that 36% of people in the UK said they were very unlikely or not sure if they would agree to be vaccinated.
“Vaccines and vaccination are two very different things,” Melinda Mills, the Oxford University professor who led the report told Reuters. “To achieve the estimated 80% of uptake of a vaccine required for community protection, we need a serious, well-funded and community-based public engagement strategy.”
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