AstraZeneca said on Thursday that it intends to submit emergency use authorization (EUA) application for its antibody combination Evusheld in India after receiving approval from US Food and Drug Administration (FDA).
Evusheld—tixagevimab co-packaged with cilgavimab—a long-acting antibody (LAAB) combination, is received for the pre-exposure prophylaxis or prevention 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 be able to mount an adequate immune response to covid-19 vaccination, as well as those for whom covid vaccination is not recommended. Recipients should not be currently infected with or had recent known exposure to a person infected with covid.
Evusheld, AstraZeneca claimed, is the only covid antibody delivered as an intramuscular dose (150mg tixagevimab and 150mg cilgavimab). The company said the first doses are expected to become available very soon. “Evusheld neutralizes all previous SARS-CoV-2 variants to date, and we are working quickly to establish its efficacy against the new Omicron variant,” Mene Pangalos, executive vice president, BioPharmaceuticals R&D, AstraZeneca, said.
According to the company, about 2% of the global population is considered at increased risk of an inadequate response to a covid vaccine. In India, this percentage could be a bit higher given the issues of underdiagnosis and ignorance, it said. This includes people with blood cancers or other cancers being treated with chemotherapy, as well as those taking medications after an organ transplant or who are taking immunosuppressive drugs for conditions including multiple sclerosis and rheumatoid arthritis, the company said in a statement.
“We have already initiated engagements with the relevant health authorities in India to provide them with the latest evidence. Recent data from the Phase III PROVENT trial showed a robust efficacy profile and AZD7442 has so far demonstrated protection of up to six months against covid-19 in this population,” Gagandeep Singh Bedi, Managing Director AstraZeneca India Pharma Limited said.
AstraZeneca said studies are under way to provide information on the impact of the new Omicron variant of coronavirus on Evusheld. The drug is being developed with support from the US government, including federal funds.
