Roche/Regeneron antibody cocktail Ronapreve approved in Japan for COVID-19
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Roche/Regeneron antibody cocktail Ronapreve approved in Japan for COVID-19. Roche/Regeneron antibody cocktail Ronapreve approved in Japan for preventive treatment of symptomatic COVID-19!
Recently, Chugai Pharma, a Japanese pharmaceutical company controlled by Roche, recently announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan has approved the antibody cocktail therapy Ronapreve (casirivimab and imdevimab, formerly known as: REGN-COV2) as a new indication : Used to prevent symptomatic SARS-CoV-2 infection (COVID-19).
This indication was approved through Special approval for Emergency in accordance with Article 14-3 of the PMD Act of Japan.
The approval allows: Ronapreve to be administered by intravenous infusion or subcutaneous injection for the treatment of unvaccinated or incomplete vaccination, close contact with COVID-19 patients, or test positive for asymptomatic COVID-19 and have a high risk of developing severe COVID -19 crowd.
When intravenous infusion is not possible due to unavoidable circumstances, subcutaneous injection can be used to treat SARS-CoV-2 infection. This indication has been previously approved.
It is worth mentioning that Ronapreve is the first antibody therapy for individuals who have been in close contact with COVID-19 patients and individuals who have tested positive for asymptomatic COVID-19 to prevent the occurrence of symptomatic COVID-19.
Data from the global Phase 3 study shows that among uninfected individuals who are in close contact with COVID-19 patients and asymptomatic COVID-19-positive individuals, Ronapreve treatment significantly reduces the risk of symptomatic COVID-19.
In July of this year, Ronapreve was approved by Japan’s MHLW for the treatment of patients with mild to moderate COVID-19 through intravenous infusion.
This indication is approved through the Special Approval Pathway in accordance with Article 14-3 of the PMD Act of Japan.
It is worth mentioning that this approval also marks Ronapreve’s first regulatory approval worldwide.
In December 2020, Chugai obtained the development and exclusive commercialization rights of Ronapreve in Japan from Roche. The company is working with the Japanese government to ensure proper and timely supply of Ronapreve.
The approval of this new indication is based on the global phase 3 clinical study (REGN-COV 2069) conducted in non-infected or infected individuals who have been in close contact with COVID-19 patients but who have not developed symptoms, and testing the dosage and administration of Ronapreve The results of a global phase 2 study (REGN COV 20145 study) of the program and a phase 1 study evaluating the safety, tolerability, and pharmacokinetics of Ronapreve in Japanese patients.
REGN-COV 2069 is a randomized, double-blind, placebo-controlled, multi-part Phase 3 study that evaluates the efficacy and safety of Ronapreve in preventing symptomatic COVID-19 infection in household contacts of COVID-19 patients.
The results of a prevention cohort of close contacts of COVID-19 patients showed that among individuals who were not infected when entering the trial, Ronapreve treatment reduced the risk of symptomatic infection by 81%.
Results from a treatment cohort of patients with asymptomatic infections recently showed that Ronapreve treatment reduced the risk of disease progression to symptomatic COVID-19 by 31%.
Dr. Osamu Okuda, President and CEO of Chugai Pharmaceutical, said: “We are very pleased that Ronaprev, as the first antibody therapy to prevent symptomatic COVID-19, will further contribute to the control of COVID-19 in Japan. Vaccines are used to prevent COVID-19.
However, some people are not suitable for vaccination, or may not fully respond to the vaccine due to underlying diseases or taking drugs. When these people have close contact with a COVID-19 infected person or test positive for asymptomatic COVID-19, Ronaprev is an important choice.
With an additional subcutaneous administration regimen, Ronapreve is expected to provide new treatment opportunities for patients with mild to moderate COVID-19 who have difficulty in intravenous administration, and help reduce the burden of family treatment.”
Ronapreve was jointly developed by Roche and Regeneron. The drug is a cocktail therapy consisting of two monoclonal antibodies (casirivimab and imdevimab).
The two monoclonal antibodies target the new coronavirus (SARS-CoV-2) spike protein (S Protein) 2 independent, non-overlapping sites in the receptor binding region have a synergistic effect, which can reduce the risk of virus mutation and escape, and protect the population from virus variants with mutations in the S protein.
In addition, data from preclinical studies indicate that casirivimab and imdevimab retain neutralizing activity against key emerging variants.
In many other regions outside Japan, casirivimab and imdevimab cocktail therapy have been authorized for emergency use or temporary pandemic use.
In the United States, casirivimab and imdevimab cocktail therapy were granted emergency use authorization (EUA) for the treatment of direct SARS-CoV-2 virus test results positive, high risk of developing severe COVID-19 and/or hospitalization, age ≥ Children and adults with mild to moderate COVID-19 who are 12 years old and weighing ≥40 kg.
The cocktail therapy of casirivimab and imdevimab should be administered by intravenous (IV) infusion; when intravenous infusion is not feasible and will cause treatment delay, subcutaneous injection (SC) is an alternative method.
Original source: The Antibody Cocktail, Ronapreve Approved for Additional Indication as a Preventive Treatment of Symptomatic COVID-19
Roche/Regeneron antibody cocktail Ronapreve approved in Japan for COVID-19
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