AstraZeneca to seek India nod for antibody cocktail

INTERNATIONAL DESK: British-Swedish drug maker AstraZeneca NSE 1.67 % said it intends to apply for emergency use authorisation (EUA) of its long-acting Covid-19 monoclonal antibody cocktail Evusheld in India.

“The US Food and Drug Administration’s EUA approval of AZD7442 for the prevention of Covid-19 is an important milestone globally… we have already initiated engagements with the relevant health authorities in India to provide them with the latest evidence,” said Gagandeep Singh Bedi, managing director, AstraZeneca India Pharma.

Evusheld is a combination of tixagevimab and cilgavimab. The drug received EUA in the US on Thursday for pre-exposure prophylaxis or preventing infection in people aged 12 years and above who are immunocompromised and those 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. The pivotal phase-3 data showed Evusheld provides at least six months of protection. About 2% of the global population is considered at increased risk of an inadequate response to a Covid-19 vaccine.

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,” said AstraZeneca.

(The Economic Times)