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

Click here  Click here read full press release/ article | Ref: AstraZeneca | Image: The Hindu Business Line