Summary :
- 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.
- 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 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 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.
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,”
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.”
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.
AstraZeneca Approach India Authority for Evusheld
About Evusheld
AstraZeneca’s Evusheld (tixagevimab co-packaged with cilgavimab), a long-acting antibody (LAAB) combination, has received emergency use authorisation (EUA) in the US for the pre-exposure prophylaxis (prevention) of COVID-19, with first doses expected to become available very soon.
The Food and Drug Administration (FDA) granted the EUA for Evusheld for pre-exposure prophylaxis of COVID-19 in adults and adolescents (aged 12 and older who weigh 40kg or more) with moderate to severe immune compromise due to a medical condition or immunosuppressive medications and who may not mount an adequate immune response to COVID-19 vaccination, as well as those individuals for whom COVID-19 vaccination is not recommended. Recipients should not be currently infected with or had recent known exposure to a person infected with SARS-CoV-2.
Evusheld and SARS-CoV-2 variants
Studies are underway to provide information on the impact of the new Omicron variant (B.1.1.529) on Evusheld.10,11 Of the Omicron binding site substitutions relevant to Evusheld that have been tested to date in preclinical assays, none have been associated with escape from Evusheld neutralisation.10,11 In vitro findings demonstrate Evusheld neutralises other recent emergent SARS-CoV-2 viral variants, including the Delta and Mu variants.10
Evusheld is being developed with support from the US government, including federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority in partnership with the Department of Defense; Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense, under Contract No. W911QY-21-9-0001.
AstraZeneca has agreed to supply the US government with 700,000 doses of Evusheld. The U.S. government has indicated that it plans to distribute these doses to states and territories at no cost and on a pro rata basis.
AstraZeneca is progressing with filings around the globe for potential emergency use authorisation or conditional approval of Evusheld in both COVID-19 prophylaxis and treatment.
About AstraZeneca
AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide