The COVID-19 vaccination has reduced the spread of the pandemic in the US, but infections are still occurring and not everyone is eligible for authorized shots. People who need COVID antibody treatment now have a more convenient option. FDA is extended emergency use To include injectable formulations for Regeneron Pharmaceuticals’ antibody cocktail, offers the option of intravenous infusion that requires patients to sit for 20 minutes or longer.
The expanded authorization announced on Friday has reduced the dosage of the Regeneron antibody cocktail — for both the IV and injectable formulations — to 1,200 mg, which is half of the initially authorized dose. But the convenience of an injectable formulation won’t be an easy, quick shot. While the IV version is injected with an infusion bag that combines two antibodies that contain the drug, the injectable version is given as four separate injections.
Injections should be given in a clinical setting where patients can be observed for response to treatment. But according to the update IV infusion is still a “strongly recommended” formulation fact sheet provided to healthcare providers.
“Subcutaneous injection is an alternative route of administration when intravenous infusion is not feasible and may lead to delay in treatment,” the fact sheet reads.
Tarrytown, New York-based Regeneron’s COVID-19 drug contains two antibodies, casirivimab and imdevimab. Both of these bind to the receptor-binding domain of SARS-CoV-2, preventing it from infecting cells. The FDA emergency authorization of the drug Regeneron covers the treatment of mild to moderate COVID-19 in adults and children 12 years of age and older who weigh 88 pounds or more. Regeneron is developing its COVID antibody drug in partnership with Swiss pharmaceutical giant Roche, which is handling clinical development and regulatory submissions outside the US.
The expanded FDA authorization for antibodies to Regeneron is based on data from clinical trials, including a recent Phase 3 study showing that the effect of the injectable formulation at a lower 1,200 mg dose was consistent with that of a higher dose. Those results also showed that the injectable version reduced the risk of hospitalization or death by 70%.
To date, more than 9,000 people in both hospitalized and non-hospitalized settings have received an intravenous version of Regeneron’s antibody drug in clinical trials. In a pooled analysis spanning all phases of the clinical trial, the most common side effects observed were infusion site reactions. In rare cases, anaphylactic reactions were reported. Injection site reactions were the most common side effects in those treated with the injectable version of the drug.
Antibody drugs remain an important treatment option as circulating variants of the novel coronavirus. In laboratory tests, the drug Regeneron has shown potent activity against the main types identified so far. So too is sotrovimab, the Antibody drug from Vir Biotechnology and GlaxoSmithKline FDA authorized Last week. Eli Lilly has third authorized COVID-19 antibody treatment, a drug that combines two antibodies. FDA canceled Authorization for Lilly’s single antibody drug, bamlanivimab, because of that drug’s efficacy against new variants.
Under an agreement with federal officials, the US government will purchase all doses of Regeneron COVID-19 antibodies that the company distributes by June 30. The company expects to deliver at least 1 million doses in the current quarter. The government may at its discretion also accept additional doses up to a maximum of 1.25 million doses by the end of September.
Regeneron said it expects to file for full FDA approval of its antibody drug for outpatient use later this summer. the company also Evaluated its drug as a preventive measure Based on drug tests in people who shared a home with a patient infected with COVID-19. Regeneron said it has submitted those clinical trial results to regulators to support the expansion of the drug’s authorization to include the prevention of COVID-19.
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