In October, former President Donald Trump praised Regeneron, the drug he was prescribed, while recovering from COVID-19 at Walter Reed Medical Center.
Trump called the treatment "unbelievable" at the time, declaring that he'd like to see the same medication be free for the public. "They call them therapeutics, but for me it wasn't therapeutic, it just made me better, I call that a cure," he stated.
Regeneron Pharmaceuticals said early Friday that the U.S. Food and Drug Administration had authorized a lower dose of its Covid-19 antibody therapy, a long-awaited development that could unlock substantially higher revenue for the company.
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The new lowered 1,200 mg dose is currently available as an alternative for treatment of which the previous 2,400 mg dose, which was injected into the vein for non-hospitalized COVID-19 patients, was not practical and could lead to delays in treatment.
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The original authorization for the higher dose was already granted in November of 2020. Regeneron was working against a deadline. Under the terms of the supply deal, the government is only required to buy REGEN-COV doses produced through the end of June, though Regeneron says that the government may accept doses delivered through the end of September.
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Competitors such as Eli Lilly, Vir Biotechnology and GlaxoSmithKline have also been working on an antibody drug. According to Reuters, these antibody cocktails are "called monoclonal antibodies, which mimic natural antibodies the body produces to fight off the infection."
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In the light of the new authorization, production has been ramped up at Regeneron. The company anticipates that, by the end of the second quarter of 2021, the drugmaker will have delivered 1 million doses or more to the US government.
There is also the possibility that the government will order up to another 1.25 million doses for use in the third quarter of 2021. Regeneron has also stated that another version of the cocktail is being developed and will be submitted for authorization soon. The new cocktail will be designed for preventative use.
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The current analyst consensus estimate for REGEN-COV sales in the second quarter is just $1.5 billion, according to FactSet.
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“Despite increased use of vaccines, thousands of patients are still becoming infected in the U.S. every day, with many at high risk of serious complications from Covid-19,” the company’s chief scientific officer, George Yancopoulos, said in a statement. “Unfortunately, to date only a fraction of patients eligible for antibody treatments have received them, which we hope will change based on this updated FDA authorization.”
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In addition to decreasing the size of the dose, the new authorization also allows subcutaneous injection of the antibody therapy when intravenous administration, the previously authorized and preferred method, isn’t feasible.
Regeneron announced it would be seeking full approval of the therapy later this summer.