Author: Karolina Kujawa
Publisher: Datamonitor Healthcare
MEDI8897 is a human immunoglobulin G1 MAb derived from human B cells intended to provide protection against RSV infection. The drug is designed to provide passive immunization against RSV-related lower respiratory tract infection in infants with a single intramuscular injection. It is currently in Phase II development in the US and EU for the prevention of RSV infection in infants.
MEDI8897 is a next-generation monoclonal antibody (MAb) with an extended half-life compared to Synagis (palivizumab; AstraZeneca/AbbVie) and the potential for an improved administration schedule. It is designed to provide protection with a single administration, which would be a major improvement over Synagis, which requires a total of five monthly doses to maintain protection across the entire respiratory syncytial virus (RSV) season. The drug was granted a fast track designation by the US Food and Drug Administration (FDA) in 2015, and Sanofi is expected to file for approval in Q4 2020 in the US and EU (Sanofi, 2017). Provided that a single dose offers similar protection to Synagis, MEDI8897 is expected to cannibalize Synagis’s sales and replace it in the US, EU, and select rest of world markets. Nevertheless, with a maternal vaccine and four infant vaccines in the pipeline, it is likely that MAbs will be rendered obsolete from the 2025/26 season onwards. However, the decision to adopt either a passive immunization or a vaccination strategy will be highly dependent on the extent of protection against severe infection provided by each intervention, and therefore Phase II and Phase III data will be necessary to evaluate the efficacies of both approaches.
4 Drug Overview
5 Product Profiles
5 MEDI8897 : Respiratory syncytial virus (RSV) vaccines
LIST OF FIGURES
11 Figure 1: MEDI8897 for RSV prophylaxis – SWOT analysis
LIST OF TABLES
6 Table 1: MEDI8897 drug profile
7 Table 2: MEDI8897 Phase II clinical trial in RSV prophylaxis
9 Table 3: MEDI8897 Phase I trial data in RSV prophylaxis
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