Nov. 9 (Reuters) – AstraZeneca’s (AZN.L) antibody cocktail against COVID-19 received its first approval for registration in Australia, the country’s medical regulatory agency said Tuesday.
The Therapeutic Goods Administration said last week it granted preliminary determination to the Anglo-Swedish drugmaker for its antibody cocktail, EVUSHELD, the first protective injection other than vaccines against COVID-19.
The regulator said the preliminary determination is the first step in the process, adding that it now expects AstraZeneca to submit an application for preliminary registration soon.
The adoption of the antibody-based therapy, which is already under real-time review in Europe and pending emergency approval in the United States, comes as Australia ramps up its vaccination rates and recently launches booster shots amid relaxed curbs.
The cocktail, which has been shown to work as a preventative injection in uninfected people, has also been shown to save lives and prevent serious illness when given as a treatment within a week of the first symptoms. read more
Reporting by Indranil Sarkar in Bengaluru; Editing by Sherry Jacob-Phillips and Shailesh Kuber
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