AstraZeneca: wins FDA breakthrough status for new antibody

(CercleFinance.com) - AstraZeneca said on Tuesday that the U.
S. Food and Drug Administration (FDA) has granted breakthrough therapy designation for MEDI8897 for the prevention of lower respiratory tract infection caused by the respiratory syncytial virus.

In Europe, the European Medicines Agency (EMA) has granted access to its "PRIority MEdicines" scheme ("Prime") for the monoclonal antibody.

The "Prime" initiative, which was launched in 2016, leads to a faster evaluation so that medicines can be marketed faster.

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