Ronapreve Approved in Japan for Preventive Treatment of Symptomatic COVID-19 Amid Global Cases Surpassing 250 Million

November 07, 2021 /BioonBIOON/ -- According to Baidu's 《Real-time Novel Coronavirus Pneumonia EpidemicBig DataReport], as of 10:00 on November 7, 2021, the global cumulative confirmed casesOver 250 million cases (250.26 million), with over 5.06 million deaths.

Recently, Chugai Pharmaceutical (Chugai Pharma), a Japanese pharmaceutical company controlled by Roche (Roche), announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approvedAntibody Cocktail Therapy Ronapreve (casirivimab and imdevimab, formerly known as: REGN-COV2): A New Indication for the Prevention of Symptomatic SARS-CoV-2 Infection (COVID-19). This indication, in accordance with Japan's "Pharmaceuticals and`Medical Devices`Act》(PMD Act) Article 14-3 through the emergency special approval pathway (SpecialappApproval for Emergency ) has been approved. This approval allows: RonapreveAdministered via intravenous infusion or subcutaneous injection for the treatment of unvaccinated or partially vaccinated individuals who have had close contact with a COVID-19 patient or who are asymptomatic and test positive for COVID-19, and are at high risk of progressing to severe COVID-19.When intravenous infusion cannot be administered due to unavoidable circumstances, subcutaneous injection may be used for the treatment of SARS-CoV-2 infection, an indication that was previously approved.

Notably,Ronapreve is the first antibody therapy used to prevent the onset of symptomatic COVID-19 in individuals who have had close contact with COVID-19 patients and in asymptomatic individuals who test positive for COVID-19.. Data from the global Phase 3 study showed that Ronapreve treatment significantly reduced the risk of developing symptomatic COVID-19 in uninfected individuals in close contact with COVID-19 patients and in asymptomatic COVID-19-positive individuals.

In July this year, Ronapreve was approved by Japan's MHLW for the treatment of patients with mild to moderate COVID-19 via intravenous infusion. This indication was granted through a special approval pathway (Special under Article 14-3 of Japan's Pharmaceuticals and Medical Devices Act (PMD Act).approval Pathway) was approved. Notably, this approval also marks the first regulatory approval for Ronapreve globally. In December 2020, Chugai Pharmaceutical Co., Ltd. (Chugai) obtained the rights to develop and exclusively commercialize Ronapreve in Japan from Roche, and the company is collaborating with the Japanese government to ensure the appropriate and timely supply of Ronapreve.

The approval of this new indication is based on the results of a global Phase 3 clinical study (REGN-COV 2069) conducted in uninfected or infected but asymptomatic individuals who were close contacts of COVID-19 patients, a global Phase 2 study (REGN COV 20145 study) evaluating the dose and dosing regimen of Ronapreve, and a Phase 1 study assessing the safety, tolerability, and pharmacokinetics of Ronapreve in Japanese patients.

REGN-COV 2069 was a randomized, double-blind, placebo-controlled, multipart phase 3 study evaluating the efficacy and safety of Ronapreve for the prevention of symptomatic COVID-19 infection in household contacts of patients with COVID-19.Results from a prophylactic cohort of household contacts of COVID-19 patients show: among individuals uninfected at trial entry, treatment with Ronapreve reduced the risk of symptomatic infection by 81%.. FromResults from a recent treatment cohort of asymptomatic patients indicate that Ronapreve treatment reduced the risk of disease progression to symptomatic COVID-19 by 31%.

REGN-COV2 (Image source: maroc-hebdo.press.ma)

Dr. Osamu Okuda, President and Chief Executive Officer of Chugai Pharmaceutical, stated: "We are very pleased that Ronapreve, as the first antibody therapy for the prevention of symptomatic COVID-19, will further contribute to the control of COVID-19 in Japan. Vaccination remains the primary approach to preventing COVID-19. However, some individuals are ineligible for vaccination, or may not mount a fully adequate immune response due to underlying medical conditions or medications. For these individuals, Ronapreve serves as an important option when they have close contact with persons infected with COVID-19 or test positive for asymptomatic COVID-19. With the addition of a subcutaneous administration regimen, Ronapreve is expected to provide new treatment opportunities for patients with mild to moderate COVID-19 for whom intravenous administration is difficult, thereby helping to reduce the burden of home-based treatment."

In multiple regions outside Japan, the casirivimab and imdevimab cocktail therapy has been authorized for emergency use or temporary pandemic use. In the United States, the casirivimab and imdevimab cocktail therapy has been granted an Emergency Use Authorization (EUA) for the treatment of pediatric and adult patients aged ≥12 years and weighing ≥40 kg with mild to moderate COVID-19, who test positive on a direct SARS-CoV-2 viral test and are at high risk for progression to severe COVID-19 and/or hospitalization. The casirivimab and imdevimab cocktail therapy should be administered via intravenous (IV) infusion; subcutaneous (SC) injection is an alternative when IV infusion is not feasible and would result in a delay in treatment. (Bioon.com)

Original Source:The Antibody Cocktail, Ronapreve Approved for Additional Indication as a Preventive Treatment of Symptomatic COVID-19