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Treatment of mild and moderate patients … by reducing virus levels
Regeneron Pharmaceuticals, a US biotechnology company, obtained emergency approval (US) for COVID-19 antibody treatment from the US Food and Drug Administration (FDA).
On the 21st (local time), the FDA decided to approve the emergency use of the combination therapy of casirivimab and imdevimab (REGN-COV2 / REGEN-COV2), a cocktail of antibodies studied for the treatment of COVID-19. He announced that he did.
Casiribimab and imdebimab combination therapy is used to treat mild to moderate Corona 19 in children 12 years of age or older, 40 kg or more, and adults who have received a positive direct corona 19 test result and have a high risk of progressing to severe Corona 19 and hospitalization. Licensed as.
Based on clinical evidence from Regeneron’s outpatient clinical trials, monoclonal antibodies such as REGEN-COV2 provide the greatest benefit to patients who have not yet generated their own immune response or who have high viral levels, and when given early after diagnosis . Showed up.
On the other hand, the combination therapy of casiribimab and imdebimab is used for patients who are hospitalized or need oxygen therapy due to Corona 19, and patients who are receiving chronic oxygen therapy due to an existing disease and need an increased flow of oxygen due to Corona 19 . Not approved.
The recommended doses of Casiribimab and Imdebimab are 1200 mg Casiribimab and 1200 mg Imdebimab (2400 mg total) given together as a single intravenous infusion.
This approval is based on positive phase 2 clinical data from 799 patients from ongoing randomized, double-blind, placebo-controlled clinical trials in non-hospital (outpatient) patients with COVID-19.
The emergency use approval is temporary and does not replace the formal Biological Product License Application (BLA) review and approval process. The safety and efficacy of casiribimab and imdebimap continue to be evaluated in several clinical trials.
Leonard Schleiper, executive director of Regeneron, said: “The FDA emergency approval is an important step in the fight against COVID-19, as it allows high-risk patients in the United States to use promising treatments in the first stages of infection, “Regeneron said for more than 30 years. Thanks to the scientific and technological investments we have made, we are moving rapidly to maximize the invention, research and production of REGEN-COV2 ”.
However, “despite this tremendous effort, demand may initially exceed supply, so it is important that the federal and state governments distribute REGEN-COV2 fairly and equitably to the patients who need it most.” We look forward to increasing the global supply of REGEN-COV2 through cooperation with us. “
“REGEN-COV2 is designed to mimic the way that a well-functioning immune system neutralizes viruses with very powerful antibodies,” said Regeneron Chief Scientist George Jankopulos.
“Data from approximately 800 outpatients show a significant decrease in virus levels within days of receiving REGEN-COV2, which was associated with a significant decrease in the number of medical visits.” “It was the highest in patients at the highest risk for poor outcomes due to high virus levels, ineffective immune responses, and existing risk factors.”
“We are encouraged to learn that no mutations in antibody cocktail resistance have been found in clinical trial analyzes to date, which is consistent with preclinical results.”
Additionally, “We are very encouraged by the promising results of the recently announced vaccine, but we need to treat COVID-19 infected patients because they cannot receive vaccines or are not protected by vaccines.” “We are continuing a rigorous program of clinical trials evaluating the safety and efficacy of our products and will announce new results as they become available.”
Regeneron plans to prepare a dose of REGEN-COV2 for about 80,000 patients by the end of this month, and a dose for about 200,000 patients by the first week of January next year, and about 300,000 patients by the end of January. I plan to prepare a dose for the treatment.
Regeneron previously signed a contract with the US government for the initial supply of REGEN-COV2 in July of this year. The US government is working with state authorities to assign REGEN-COV2 each week based on the number of confirmed corona19 cases in each state.
The US government has decided to provide 300,000 doses of REGEN-COV2 to patients free of charge.
However, medical centers may charge patients drug-related fees.
Regeneron has decided to begin shipping REGEN-COV2 soon to Amerisource Bergen, a distributor that will distribute the treatment, as directed by the US government.
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