AstraZeneca's Evusheld nabs its first global nod as a COVID treatment

AstraZeneca’s COVID-19 antibody Evusheld nabbed its first global nod as a coronavirus treatment. Already authorized in many places to prevent infection prior to exposure, the drug is set to reach a broader set of patients in Japan.

Japan’s Ministry of Health, Labour and Welfare has endorsed the drug in people 12 and older. For the prevention nod, Evusheld is approved for people who may have an “inadequate” response to the COVID-19 vaccines because of immunodeficiencies. For the treatment use, the drug is approved for people who are at risk of severe infection.

With the approval, the Japanese government agreed to purchase 300,000 courses of the drug.

The approvals represent an “important milestone” in AstraZeneca’s efforts to combat the pandemic, Mene Pangalos, AstraZeneca’s head of biopharma R&D, said in a company statement. “Evusheld 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.”

The regulator based the approvals on a broad set of data on the medicine, including results from a phase 3 pre-exposure prophylaxis trial and a phase 3 outpatient treatment trial.

The Japanese approvals come after the setback for the company in its home country. In the U.K., officials recently said they will not purchase the drug. They cited “insufficient data” on the duration of protection it provides against the dominant variant omicron and its subvariants.

Meanwhile, the U.S. expanded its supply deal for the drug in February.