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Sanofi/AstraZeneca’s Nirsevimab Is Set To Transform RSV Treatment In Infants

 
• By Brenda Sandburg

Sanofi executives discuss ongoing efforts to make the monoclonal antibody available for the next RSV season and the impact it will have as the first prophylactic treatment for all infants. An FDA advisory committee is expected to discuss the biologics license application at a yet-to-be announced meeting.

RSV infants
The biologics license application for the first RSV prophylaxis for all infants is under FDA review. • Source: Shutterstock

The decades long quest for a treatment to protect all infants from respiratory syncytial virus (RSV) infection is coming to fruition as Sanofi and AstraZeneca PLC’s monoclonal antibody nirsevimab is now under review at the US Food and Drug Administration. If approved, the product would be the first treatment to prevent RSV in all newborns and infants.

Swedish Orphan Biovitrum AB (Sobi)’s Synagis (palivizumab) has been the sole treatment option. However, it is indicated only for...

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Off-Patent Drugs Get UK Spotlight, But Picture Is Still ‘Nuanced’

 
• By Urtė Fultinavičiūtė

The importance of generic and biosimilar medicines is being recognized by the UK government for the first time. However, Mark Samuels, CEO of Medicines UK, the trade body representing the off-patent industry, says companies are still face multiple hurdles in the market.

AI In Clinical Research: Benefits Across The Board, But ‘Nirvana’ Still Out Of Reach

 
• By Vibha Sharma

Generative artificial intelligence tools, such as ChatGPT, have “democratized” AI, and contract research organizations are wholeheartedly embracing these tools, given their focus on efficiency, says Stephen Pyke, who chairs the AI committee at the Association of Clinical Research Organizations.

Vaccine Developers To Benefit From CEPI’s ‘World First’ Adjuvant ‘Matchmaking’ Service

 
• By Eliza Slawther

Selected vaccine developers will soon be able to use a new adjuvant “matchmaking” initiative that could help create more “effective, potent” vaccines against epidemic and pandemic threats, the Coalition for Epidemic Preparedness Innovations has said.

Animal Testing Alternatives: US Pharmacopeia On Its Testing Transition

 
• By Eliza Slawther

In this second of a two-part series of articles, US Pharmacopeia CEO Ronald T. Piervincenzi tells the Pink Sheet which animal testing models have alternative options and highlights where further investment and research is needed to develop appropriate alternatives.

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New Advisory Group To Shape UK’s Simplified Informed Consent Process

 
• By Anabel Costa-Ferreira

Although the UK Health Research Authority’s initial proposal for simplified informed consent was rejected by stakeholders, it has yielded valuable insights into reducing trial burden and widening access

Ultragenyx Says CRL Discussions ‘Productive’ Despite US FDA Leadership Upheaval

 
• By Jessica Merrill

Ultragenyx said talks with the FDA about a path forward after receiving a CRL for UX111 have been productive despite the recent upheaval at the agency.

Prasad 2.0 Brings New Instability Concerns, Questions About Changed Regulatory Philosophy

 
• By Sarah Karlin-Smith

Many agency stakeholders believe Vinay Prasad may be forced to change his regulatory approach at least somewhat after receiving a second chance to lead the US FDA's biologics center.