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EMA begins review of new drug developed by AstraZeneca

EMA begins review of new drug developed by AstraZeneca
EMA begins review of new drug developed by AstraZeneca

The European Medicines Agency (EMA) announced on Thursday that it had started the evaluation procedure for a new drug against the coronavirus, developed by the Swedish-British laboratory ” AstraZeneca« .

« The EMA Committee for Medicinal Products for Human Use (CHMP) has started an ongoing review of Evusheld (…), a combination of two monoclonal antibodies (tixagevimab and cilgavimab), which is being developed by AstraZeneca for the prevention of Covid-19 in adults“Says the European Medicines Agency in a press release.

According to the EMA, the CHMP’s decision to initiate the continuous review is based on preliminary results from clinical studies, which have shown that this drug can be used effectively to protect against Covid-19.

→ Read also: Delivery of vaccines: the EU and AstraZeneca reach an agreement putting an end to their dispute

« EMA has started evaluating data from laboratory and animal studies (non-clinical data)“Says the Agency, noting that it will assess more data on the quality, safety and efficacy of the drug as it becomes available.

The ongoing review, adds the EMA, will continue until sufficient evidence is available for AstraZeneca to submit a formal application for marketing authorization.

According to the EMA, the pharmaceutical company has not yet applied for authorization for the European market. So far, only the drug Remdesivir has been approved in the European Union as a special drug against the coronavirus. Approval procedures for five other treatments are still ongoing.

(With MAP)

Source

EMA begins review drug developed AstraZeneca

 
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