Treatment for Covid-19 approved in Europe, Japan

AN antibody cocktail for the treatment of Covid-19 among adults and adolescents has been approved in the European Union and Japan, according to its manufacturer, AstraZeneca.

The AZD7442 cocktail combines two long-acting antibodies — tixagevimab and cilgavimab — which was derived from B-cells donated by convalescent patients after infection from Covid-19.

The monoclonal antibodies cling to distinct sites of the SARS-CoV2 virus spike protein and were optimized by AstraZeneca with a half-life extension that triples the durability of its action as compared to conventional antibodies.

It was developed by Vanderbilt University and AstraZeneca and was funded by the US government.

The cocktail has been approved by the European Commission to treat Covid-19 infections among adolescents and adults ages 12 years old and above and weighing at least 40 kilograms.

It has also been granted by the Japanese Ministry of Health, Labor, and Welfare a special approval for emergency for both treatment in the same age group with known risk factors for severe Covid-19 infection.

Aside from treatment, the Japanese health ministry also approved it as an alternative for Covid-19 vaccination for those who have an inadequate response to a Covid-19 vaccine due to immunodeficiencies.

Those who will receive the drug should not be infected or have had recent exposure to a Covid-infected person.

With the approval, the Japanese government is slated to purchase 300,000 units of the AZD7442 cocktail, with the aim of making the first doses available as soon as possible.

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. Itaru Matsumura of the Kindai University Faculty of Medicine adds that there are still large Covid-19 infections in Japan despite the progress of vaccinations and stringent safety precautions.

“The approval of AZD7442 is expected to provide a non-vaccine prophylactic option for those who cannot expect a full immune response from Covid-19 vaccination, such as patients with blood cancers,” Itaru said.

Dr. Michel Goldman, former executive director of the European Innovative Medicines Initiative, said that the AZD7442 cocktail is a “much-needed new Covid-19 treatment option for vulnerable populations.”

Mene Pangalos, executive vice president for Biopharmaceuticals Research and Development, AstraZeneca said that the approvals in both Japan and the European Union represent an important milestone in their ongoing efforts to help combat Covid-19 on all fronts.

“AZD7442 is now the only longacting antibody combination authorized for both Covid-19 prevention and treatment, allowing us to help protect even more vulnerable patients such as the immunocompromised from this devastating disease,” Pangalos added.

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 symptomatic Covid-19 by as much as 77 percent compared to placebo, and reduced the risk of progression to severe Covid-19 and death by as much as 50 percent.

It has also shown in-vitro neutralization of the BA.5 subvariant of the Omicron Covid-19 variant, which is now the dominant variant in Europe, and is showing also real-world effectiveness during the clinical trial period, where most Omicron variants such as BA.5, BA.4, BA.2, BA.1 and BA.1.1 were circulating.

Aside from the European Union and Japan, it has been given emergency use authorization in the US as a pre-exposure prophylaxis, while regulatory submissions are progressing for both prevention and treatment indications across the globe.

The cocktail has not yet been given any emergency use authorization in the Philippines.