COVID-19: AstraZeneca in touch with Indian authorities for approval of drug

Biopharmaceutical multinational AstraZeneca on Thursday said it has initiated engagements with Indian health authorities to provide the latest evidence of Evusheld, its COVID-19 prevention drug for people with weakened immune system which has received emergency use authorisation (EUA) in the US.

The long acting antibody combination has been granted the EUA in the US for COVID-19 prevention in adults and adolescents (above 12 years and weighing 40kg or more) with moderate to severely weakened immune system who may not have an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended, the company said.

“We welcome this news and the opportunity it provides to support the unmet needs of high risk and immune-compromised patients and we have already initiated engagements with the relevant health authorities in India to provide them with the latest evidence,” AstraZeneca India Pharma Ltd Managing Director Gagandeep Singh Bedi said in a statement.

Stating that the Food and Drug Administration’s EUA approval for Evusheld is an important milestone globally, he said, “Recent data from the Phase III PROVENT trial showed a robust efficacy profile and AZD7442 (Evusheld) has so far demonstrated protection of up to six months against COVID-19 in this population.” “In India, the company intends to submit its application after emergency use authorisation by USFDA with a hope that addition of this monoclonal antibody cocktail will provide adequate ammunition in fight against COVID-19 disease especially for high risk vulnerable and immunocompromised patients,” AstraZeneca said.

About 2 per cent of the global population is considered at increased risk of an inadequate response to a COVID-19 vaccine, it added.

“In India, this percentage could be a bit higher given the problem of underdiagnosis and ignorance. This includes people with blood cancers or other cancers being treated with chemotherapy, and those taking medications after an organ transplant or who are taking immunosuppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis,” the company said.

Evusheld is a combination of two long-acting monoclonal antibodies and is the only antibody therapy authorised in the US for COVID-19 pre-exposure prophylaxis. It is delivered as an intramuscular dose, the company said.

AstraZeneca Executive Vice President, BioPharmaceuticals R&D Mene Pangalos said, “…with Evusheld, we now have the first antibody therapy authorised in the US to prevent COVID-19 symptoms before virus exposure, while also providing long lasting protection with a single dose.” Pangalos further said, “Evusheld neutralises all previous SARs-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant. We thank our clinical trial participants, the investigators, scientists, and government agencies and our colleagues at AstraZeneca who have all contributed to the development of Evusheld.” The company also said studies are underway to provide information on the impact of the new Omicron variant on Evusheld, which is being developed with support from the US government.

AstraZeneca said it has agreed to supply the US government with 7 lakh doses of Evusheld, while it is progressing with filings around the globe for potential emergency use authorisation or conditional approval of Evusheld in both COVID-19 prophylaxis and treatment.