Trailing Eli Lilly by 12 days, Regeneron gets the FDA OK for their Covid-19 antibody cocktail
A month and a half after becoming the experimental treatment of choice for a newly diagnosed president, Regeneron’s antibody cocktail has received emergency use authorization from the FDA. It will be used to treat non-hospitalized Covid-19 patients who are at high-risk of progressing.
Although the Rgeneron drug is not the first antibody treatment authorized by the FDA, the news comes as a significant milestone for a company and a treatment scientists have watched closely since the outbreak began.
Data the company released at the end of last month showed the drug, known as REGN-CoV2, reduced virus levels and hospitalization rates in newly diagnosed patients. Ideally, it could be used to prevent severe disease in the elderly and people with multiple comorbidities at a time when cases and hospitalizations are surging to record levels across the country.
Along with the Eli Lilly treatment the FDA authorized earlier this month, REGN-CoV-2 will roughly double the amount of antibody drug available this year. No other drug is available for outpatients.
Still, the impact may not be as profound as many had hoped it would be in the spring or summer. A trial for patients on oxygen was aborted after failing a risk-benefit calculation, ending hopes that the drug could help in severe disease. And although the federal government invested over the summer in expanding Regeneron’s capacity, supply will still be severely limited.
The biotech expects 80,000 doses to be available this month, which is less than the number of diagnoses just in the state of Illinois in the last week. Although most cases are not high-risk and not-eligible, experts pointed out after the Eli Lilly EUA that in some communities, the majority of people are.
Regeneron CEO Leonard Schleifer acknowledged the likely constraints and pushed for the government to play a heavy hand in distribution.
“This FDA Emergency Use Authorization is an important step in the fight against COVID-19, as high-risk patients in the United States will have access to a promising therapy early in the course of their infection,” he said in a statement. “Even with these incredible efforts, demand may exceed supply initially, making it even more critical that federal and state governments ensure the casirivimab and imdevimab antibody cocktail is distributed fairly and equitably to the patients most in need.”
The government has already sent states two deliveries of the Eli Lilly antibody, but it remains unclear how and to whom many of those doses will be given out.
There are lingering questions around how medical centers will administer the antibody treatments, which have to be infused over the course of an hour but are indicated only for patients who are not hospitalized. With hospitals around the country reaching capacity, some have considered simply turning down the Eli Lilly antibody, rather than try to administer it while simultaneously handling huge influxes of severe Covid-19 patients.
Adding to their reticence were the sparse data around the Eli Lilly’s antibody: The low dose the FDA authorized had failed the primary endpoint in the pharma’s study, and the Infectious Disease Society of America recommended against prescribing it.
Regeneron has arguably shown stronger data, but they have not disclosed results for the low dose they plan to deliver to patients. They have also not released data on whether the drug helped alleviate symptoms, disappointing some analysts.
The company expects to be able to make 300,000 doses by the first week of January. A partnership with Roche, expected to get fully online at the start of 2021, should allow them to churn out 250,000 doses per month, executives said in late September.
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