AstraZeneca's MEDI8897 Receives FDA's Breakthrough Therapy Designation (BTD) & EMA's PRIME Designation for Lower Respiratory Tract Infection (LRTI) in Infants
Shots:
- The FDA’s BT & EMA’s PRIME designation is based on P-IIb trial results assessing MEDI8897 in patients with LTRI caused by respiratory syncytial virus (RSV) in premature infants @150 days
- The P-IIb study resulted in meeting its 1EPs with reduction in the incidence of medically-attended LRTI
- MEDI8897 is an extended half-life RSV F mAb- used for prevention of LRTI administered as a single dose within 5months and has received FDA’s FT designation in Mar-2015. In Mar- 2017 AstraZeneca and Sanofi Pasteur collaborated to jointly commercialize MEDI8897
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