Antibody cocktail for Covid-19 approved in Europe, Japan
An antibody cocktail for the treatment of coronavirus disease 2019 (Covid-19) among adults and adolescents has been approved in both the European Union and Japan, according to its manufacturer, AstraZeneca.
The AZD7442 has been approved by the European Commission as treatment for adolescents 12 years old and above and weigh at least 40 kilograms and adults.
It has also been granted by the Japanese Ministry of Health, Labor, and Welfare a special approval for emergency treatment in the same age groups with known risk factors for severe Covid-19 infection.
Aside from treatment, the Japanese health ministry also approved the cocktail as an alternative to vaccination for those who have inadequate response due to immunodeficiencies.
Those who will receive the drug should not be currently infected or have had recent exposure to a Covid-infected person.
Dr. Kazuhiro Taneda, professor of the Department of Microbiology and Infectious Diseases at Toho University, said that the antibody cocktail is a “much-needed new option, offering long-term protection for those who do not achieve an adequate immune response after vaccination and helping prevent severe disease and death in those who do become infected.”
Dr. Michel Goldman, former executive director of the European Innovative Medicines Initiatie, said that the AZD7442 cocktail is a “much needed new Covid-19 treatment option for vulnerable populations.”
The approvals were based on the safety and efficacy data from the PROVENT phase 3 pre-exposure prophylaxis trial and TACKLE phase 3 clinical treatment trial for the antibody cocktail.
The trials showed a reduction of developing symptoms of Covid-19 by as much as 77 percent compared to the placebo, and reduced the risk of progression to severe Covid-19 and death by as much as 50 percent.
The cocktail has not yet been given any emergency use authorization in the Philippines.