Breakthrough status and PRIME eligibility for potential next-generation RSV drug MEDI8897

5 February 2019

The US Food and Drug Administration has granted Breakthrough Therapy designation (BTD) for MEDI8897, an extended half-life respiratory syncytial virus (RSV) F monoclonal antibody (MAb) being developed for the prevention of lower respiratory tract infection (LRTI) caused by RSV.

The MAb is under development by AstraZeneca (LSE: AZN), whose shares gained 1.29% to 5,640 pence by mid-day trading, and its US biotech unit MedImmune.

A BTD is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition and that have shown encouraging early clinical results, which may demonstrate substantial improvement on a clinically-significant endpoint over available medicines.

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