EU, Japan approve AstraZeneca’s Covid treatment

AN ANTIBODY drug for the treatment of Covid-19 has recently been approved in Europe and Japan.

In a statement sent to SunStar Cebu, the European Union (EU) approved the use of AstraZeneca’s AZD7442 to treat Covid-19 infections among adolescents and adults aged 12-years-old and above and weighing at least 40 kilograms.

AZD7442 is a combination of two long-acting antibodies—tixagevimab and cilgavimab--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.

AZD7442 was developed Vanderbilt University Medical Center and AstraZeneca, funded by the US government.

AZD7442 was granted marketing authorization in the EU for the prevention of Covid-19 in a broad population of adults and adolescents earlier this year and is already available in most countries in Europe.

Similarly, the Japanese government also approved AZD7442 for both the prevention and treatment of Covid-19. The decision marked the first global marketing approval for AZD7442 as a treatment for Covid-19.

Japan’s Ministry of Health, Labor and Welfare granted AZD7442 Special Approval for Emergency for adults and adolescents aged 12 years old and older weighing at least 40 kilograms. AZD7442 is approved for the treatment of those with risk factors for severe Sars-CoV-2 infection in Japan.

With this approval, the Japanese government is set to purchase 300,000 units of AZD7442 (150mg each of tixagevimab and cilgavimab). AstraZeneca is working with the government and partners to make first doses available as soon as possible.

These developments come at a time when economies in the world are opening up, lifting restrictions and recuperating industries; and as governments prioritize health to rebuild economies.

In the Philippines, however, AZD7442 has not yet been approved.

Mene Pangalos, executive vice president, BioPharmaceuticals R&D at AstraZeneca said the approvals of AZD7442 represent an important milestone in the firm’s ongoing efforts to help combat Covid-19 on all fronts.

“AZD7442 is now the only long-acting 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,” she said.

Dr. Michel Goldman, former executive director of the European Innovative Medicines Initiative, said this new development should benefit the vulnerable sector of society, including those who are immunocompromised, older adults and those with underlying health conditions, who are at high risk of severe disease, hospitalization, and death if they become infected by the virus.

“AZD7442, delivered in a convenient intramuscular formulation, is now a much-needed new Covid-19 treatment option for these vulnerable populations,” he said.

Phase 3 clinical trials

AstraZeneca said 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.

Dr. Itaru Matsumura, professor and chairman, Department of Hematology and Rheumatology, Kindai University Faculty of Medicine, Otsuka, Japan, said “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.”

He noted that despite the progress of vaccinations and stringent safety precautions, there is still a large number of new infections in Japan.

“AZD7442 will be 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,” added Kazuhiro Tateda, professor, the Department of Microbiology and Infectious Disease, Toho University, Tokyo, Japan.

Besides EU and Japan, AZD7442 is authorized for use for pre-exposure prophylaxis (prevention) of Covid-19 in the US (emergency use), EU, Japan and many other countries. Regulatory submissions are progressing for both prevention and treatment indications around the world.

Globally, there have been 616,951,418 confirmed cases of Covid-19, including 6,530,281 deaths, reported to the World Health Organization. As of Oct. 3, 2022, a total of 12,723,216,322 vaccine doses have been administered.