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AstraZeneca: RSV Medicine MEDI8897 Gets FDA's BTD, EMA's PRIME Eligibility

British drug maker AstraZeneca Plc (AZN.L,AZN) and its biologics research and development arm, MedImmune, announced that the US Food and Drug Administration has granted Breakthrough Therapy Designation for MEDI8897, a next-generation preventive medicine for respiratory syncytial virus or RSV.

Separately, AstraZeneca announced that the European Medicines Agency or EMA has granted access to its PRIME scheme for MEDI8897.

The company noted that MEDI8897is an extended half-life respiratory syncytial virus or or RSV F monoclonal antibody or mAb being developed for the prevention of lower respiratory tract infection or LRTI caused by RSV.

The FDA designation is based on positive primary analysis of the Phase Iib trial that demonstrated the safety and efficacy of MEDI8897.

The company noted that MEDI8897 is being developed in partnership with Sanofi Pasteur and received Fast Track designation from the US FDA in March 2015.

Mene Pangalos, Executive Vice-President, R&D BioPharmaceuticals, said, "The Breakthrough Therapy Designation, together with its recent PRIME eligibility from the European Medicines Agency, will help us to bring MEDI8897 to all infants at risk for RSV as quickly as possible."

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