+353-1-416-8900REST OF WORLD
+44-20-3973-8888REST OF WORLD
1-917-300-0470EAST COAST U.S
1-800-526-8630U.S. (TOLL FREE)

PRINTER FRIENDLY

Disease Analysis: Respiratory Syncytial Virus (RSV) Prevention

  • ID: 5304683
  • Report
  • February 2021
  • Region: Global
  • 44 pages
  • Datamonitor Healthcare
1 of 2
Latest Key Takeaways
  • The RSV prophylaxis market is expected to expand rapidly over the next 10 years, triggered by the anticipated launches of nirsevimab and various vaccine approaches from the 2024/25 season. The RSV pipeline remains active with vaccines being developed for the three major risk groups, namely the elderly, infants, and pregnant women (to protect infants via passive transfer of neutralizing antibodies across the placenta).
  • Synagis is currently the only marketed preventive agent in the RSV space and generates blockbuster sales. Notably, the use of Synagis is severely restricted to niche risk groups in infants because pivotal trial data showed only moderate efficacy against RSV hospitalization in patients with chronic lung disease (CLD) or congenital heart disease (CHD), as well as by its very high cost per dose. With no competition in the near term, and no biosimilars likely to enter clinical development, Synagis's sales are expected to remain stable until the 2023/24 season, after which the anticipated approval of AstraZeneca/Sanofi’s next-generation antibody nirsevimab as early as the 2024/25 season threatens to render Synagis redundant.
  • Nirsevimab, a next-generation monoclonal antibody with an improved once-per-season dosing schedule, is likely to succeed Synagis as the new standard of care in the 2024/25 season if ongoing pivotal trials are successful. Sanofi is intending to price nirsevimab comparably to other pediatric vaccines to facilitate reimbursement for universal use as an at-birth dose. Phase IIb data have shown a promising reduction in RSV hospitalizations compared to placebo (-78%), thus the publisher believes nirsevimab poses a severe threat to maternal vaccines which also aim to provide protection during the first six months of life (the highest risk period for RSV hospitalization), but the effectiveness of the latter will be hampered by poor vaccination coverage rates in pregnant women.
  • Vaccines in development for maternal immunization include Novavax’s ResVax, Pfizer’s PF-06928316, and GlaxoSmithKline’s GSK3888550A. ResVax narrowly missed its primary efficacy endpoint in the pivotal PREPARE study, and while it hit key secondary endpoints, the EMA and FDA have requested an additional confirmatory efficacy study before considering approval. While Novavax seeks funding from a willing development partner, Pfizer and GlaxoSmithKline have taken the lead with ongoing pivotal trials expected to reach primary completion in August 2023, paving the way for potential launch in time for the 2024/25 RSV season.
  • Maternal vaccines are under threat from AstraZeneca/Sanofi’s nirsevimab, which Phase IIb data suggest will be able to provide protection from RSV hospitalization for the first five to six months after a single at-birth dose. This approach could be preferred because much higher coverage rates could be achieved than with maternal vaccination, potentially leading to a greater reduction in clinical morbidity and mortality.
  • The elderly segment offers the most commercial potential because of the large population size, high coverage rates that can be achieved, and the likely requirement for repeat seasonal vaccination. ResVax also failed to meet its primary efficacy endpoint in this subgroup in the RESOLVE study, leaving the door open for a host of challengers to steal first-to-market status. The new frontrunner in the elderly segment, GlaxoSmithKline, has stated its intention to initiate a pivotal Phase III trial to show protective efficacy in 2021/22 RSV season. The trial will cross two RSV seasons, therefore the vaccine will gain approval at the earliest towards the end of 2023, with possible use beginning from the 2024/25 season. Other competitors include Pfizer’s adjuvanted formulation of PF-06928316 and Johnson & Johnson’s JNJ-64400141, which could also enter Phase III development in either 2021 or 2022 if ongoing Phase II studies are positive. Although Bavarian Nordic was previously the frontrunner, the company has chosen to defer its Phase III trial to the 2022/23 season due to low enrollment during the COVID-19 pandemic.
  • Pediatric vaccines in development include GlaxoSmithKline’s GSK3389245A, Johnson & Johnson’s JNJ-64400141, Sanofi’s portfolio of live-attenuated vaccines (LAVs) and Meissa Vaccine’s MV-012-968. GlaxoSmithKline’s and Johnson & Johnson’s candidates seem the most promising because of their ability to be administered at two to three months of age, while Sanofi’s LAVs are limited to six months of age because of the risk of neutralization by pre-existing anti-RSV antibodies (transferred to infants via the placenta). Both GlaxoSmithKline’s and Johnson & Johnson’s vaccines are in Phase II trials; however, with GSK3389245A achieving positive results in 2020, it is likely to be the first pediatric vaccine to enter Phase III trials and reach the market, aided by its fast track status.
Note: Product cover images may vary from those shown
2 of 2
OVERVIEW
  • Latest key takeaways
DISEASE BACKGROUND
  • Definition
  • Symptoms
  • Transmission
  • Risk factors
  • Prevention
TREATMENT
  • Passive immunization guidelines
MARKETED PREVENTIVE AGENTS

PIPELINE PREVENTIVE AGENTS

PROBABILITY OF SUCCESS

LICENSING AND ASSET ACQUISITION DEALS
  • Moderna Takes Back RSV Vaccine Licensed to Merck & Co.
  • Codagenix Raises $20m in Series B Financing
CLINICAL TRIAL LANDSCAPE
  • Sponsors by status
  • Sponsors by phase
RSV PREVENTION ASSESSMENT
  • Synagis
  • Nirsevimab
  • MK-1654
  • ResVax
MVA-BN RSV
  • JNJ-64400141
  • PF-06928316
  • GSK3888550A and GSK3844766A
  • GSK3389245A
  • Live-attenuated vaccines – SP-0125
  • MV-012-968
MARKET DYNAMICS

FUTURE TRENDS

CONSENSUS FORECASTS

RECENT EVENTS AND ANALYST OPINION
  • Nirsevimab for Respiratory Syncytial Virus (RSV) (July 29, 2019)
KEY UPCOMING EVENTS

UNMET NEEDS

BIBLIOGRAPHY
  • Prescription information
APPENDIX

LIST OF FIGURES
  • Figure 1: Overview of pipeline RSV preventive agents in the US
  • Figure 2: Pipeline RSV preventive agents, by company
  • Figure 3: Pipeline RSV preventive agents, by drug type
  • Figure 4: Pipeline RSV preventive agents, by classification
  • Figure 5: Probability of success in the antiviral pipeline
  • Figure 6: Clinical trials in RSV vaccines and therapeutic agents
  • Figure 7: Top 10 drugs for clinical trials in RSV vaccines and therapeutic agents
  • Figure 8: Top 10 companies for clinical trials in RSV vaccines and therapeutic agents
  • Figure 9: Trial locations in RSV vaccines and therapeutic agents
  • Figure 10: RSV vaccines and therapeutic agents trials status
  • Figure 11: RSV vaccines and therapeutic agents, by phase
  • Figure 12: Market dynamics in RSV prevention
  • Figure 13: Future trends in RSV prevention
  • Figure 14: Nirsevimab for Respiratory Syncytial Virus (RSV) (July 29, 2019): Phase IIb - Healthy Preterm Infants
  • Figure 15: Key upcoming events in RSV prevention
LIST OF TABLES
  • Table 1: Recommendations for palivizumab immunization by national authorities, 2020
  • Table 2: Marketed RSV preventive agents
  • Table 3: Pipeline RSV preventive agents
  • Table 4: Historical global sales, by product ($m), 2015–19
  • Table 5: Forecasted global sales, by product ($m), 2021–25
  • Table 6: Nirsevimab for Respiratory Syncytial Virus (RSV) (July 29, 2019)
Note: Product cover images may vary from those shown
Adroll
adroll