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Thursday, May 23, 2024

Thailand approves Roche/Regeneron’s “antibody cocktail” for COVID-19 patients

 On July 15, 2021, the Food and Drug Administration (FDA) of Thailand announced the approval of the “antibody cocktail” for the treatment of COVID-19 patients, streamlining through an Emergency Use Authorization or EUA. Prior to this, the European Medicines Agency (EMA) has also announced their recommendation to treat COVID-19 patients using said antibody cocktail.[2]  Additionally, the United States Food and Drug Administration  (USFDA)[3], India’s Central Drugs Standards Control Organisation (CDSCO)[4] and many other countries have gradually approved the use of the antibody cocktail under Emergency Use Authorization (EUA).

Most recently, Japan became the first country in the world to grant a Special Approval Pathway (Marketing Authorisation) for the treatment of patients with mild to moderate COVID-19 with the antibody cocktail, based on the announcement from the Ministry of Health, Labour and Welfare (MHLW) under article 14-3 of the Pharmaceuticals and Medical Devices Act (PMDA). [5]

The antibody cocktail, which is a product jointly developed by Roche and Regeneron, is proven to be effective in treating patients aged 12 years and above, with mild to moderate COVID-19. The antibody cocktail can also be used to treat patients who are at high risk of severe or progressing to severe COVID-19, such as the elderlies and people with obesity or other chronic diseases.[6]

Sansanee Lerdlitruangsin, MD., Medical Director, Roche Thailand, stated “Based on a recent research on the efficacy of Roche’s antibody cocktail, results suggest that the product is able to reduce the viral load within the infected patient’s body. It can also reduce hospitalisation time by up to four days, as well as reduces the risk of progression to severe COVID-19, which leads hospitalisation or death by up to 70%. As for the question of whether or not the antibody cocktail has an ability to retain activity against emerging variants, such as Beta, Alpha, Gamma and Delta; despite in vitro studies from the National Institutes of Health (NIH) suggesting that the antibody cocktail is susceptible to SARS-CoV-2 variants, there are no in vivo efficacy as of now.”

In addition to being an innovative treatment that has been clinically proven to be effective, it can be said that the antibody cocktail is an important catalyst to help mitigate various impacts of this health crisis. This includes hospitalized patients, and patients waiting in line for hospital beds – who will be able to receive a timelier access to treatment due to faster hospital bed turnover rate. This in turn will help lessen caregivers’ anxiety, who are likely to grieve over the loss of their loved ones, help reduce the workload of medical professionals, and help medical centers sustain resource management, such as such as hospital beds, Personal Protective Equipment (PPE), and ventilators.

Mr. Farid Bidgoli, General Manager, Roche Thailand, Myanmar, Cambodia and Laos stated, “Amidst the current pandemic that is increasing in severity, Roche Thailand is committed to leveraging our expertise and excellence in science to drive medical advancements and collaborate with various organisations to support medical professionals in fighting this deadly disease. I want to extend my deepest gratitude towards all stakeholders involved in caring for the health of the population and recognising the necessity of allowing access to effective medicines which significantly reduce the length of hospitalization and relieve anxiety from the risk of progressing to severe COVID-19 or death. I truly believe that timely access to diagnostic solutions and treatment innovations will be a key helping hand for Thailand to tackle with and put an end to this devastating pandemic once and for all.”

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