JThe Food and Drug Administration on Friday authorized another Covid-19 monoclonal antibody treatment, which will expand the offering of those treatments that work against the Omicron variant and its sister viruses.
The therapy, bebtelovimab, was developed by Eli Lilly. Like other monoclonals, it is given intravenously and is intended to prevent high-risk patients with Covid-19 from getting so sick that they need to be hospitalized.
The federal government on Thursday announcement he had struck a deal with Lilly to buy 600,000 courses of the treatment for at least $720 million. Shipments were due to begin imminently, with 300,000 courses arriving this month and another 300,000 next month. The contract includes an option for an additional 500,000 lessons.
The FDA said bebtelovimab should be used for patients “for whom alternative Covid-19 treatment options…are not accessible or clinically appropriate.”
Still, the news will bring some relief to providers who have been scrambling to find treatments for their high-risk patients. The two most common antibody therapies from the start of the pandemic – another Lilly treatment and one from Regneron – lost their effectiveness against the Omicron variant, which quickly became dominant late last year. The government has halted distribution of both therapies.
Another monoclonal treatment – sotrovimab from GlaxoSmithKline and Vir Biotechnology – maintained its potency against Omicron, but shortages meant the government was handing out some 50,000 courses of treatment every week, even though millions of infections have been reported during the same period.
Lilly said lab tests indicated that bebtelovimab not only worked against the most common Omicron variant – technically known as BA.1 – but also maintained its effectiveness against a sister line called BA.2. Although the latter represents only a small fraction of infections in the United States at this time, it is more transmissible than BA.1 and its prevalence is expected to increase. BA.2 is dominant in countries like India, Denmark and South Africa.
It is not yet clear whether sotrovimab works against BA.2.
Other options for treating Covid-19 patients who are not yet hospitalized include two antiviral pills, one from Pfizer and one from Merck, and Gilead’s remdesivir, an intravenous antiviral.
With supply constraints, therapies are typically reserved for people at high risk of severe Covid-19.