Treatment and prophylaxis of respiratory syncytial virus (RSV) disease - Scientific guideline

The guideline covers the clinical development of vaccines and monoclonal antibodies for the prevention of RSV disease and direct acting antiviral agents (DAAs) for the treatment of RSV disease. The focus is on the assessment of safety and efficacy in populations most likely to develop RSV lower respiratory tract infection and severe RSV disease, including (newborn) infants and toddlers, older paediatric subjects predisposed to develop severe RSV disease and the elderly. The guideline also addresses vaccination of pregnant women with the aim of preventing RSV disease in their infants.

Some considerations are proposed on nonclinical investigations of efficacy and risk of vaccine-associated enhanced disease to support clinical trials with preventive or therapeutic products directed at RSV.

Keywords: Respiratory syncytial virus, bronchiolitis, severe RSV disease, case definition, clinical and laboratory confirmation, vaccine-associated disease enhancement, vaccination of pregnant women, monoclonal antibodies, direct acting antiviral agents, rapid diagnostic tests

Current effective version

Guideline on the clinical evaluation of medicinal products indicated for the prophylaxis or treatment of respiratory syncytial virus (RSV) disease - First version

AdoptedLegal effective date: 01/05/2019Reference Number: EMA/CHMP/257022/2017

Document history

Guideline on the clinical evaluation of medicinal products indicated for the prophylaxis or treatment of respiratory syncytial virus (RSV) disease - First version

AdoptedLegal effective date: 01/05/2019Reference Number: EMA/CHMP/257022/2017

Overview of comments received on 'Draft guideline on the clinical evaluation of medicinal products indicated for the prophylaxis or treatment of respiratory syncytial virus (RSV) disease' (EMA/CHMP/257022/2017) - First version

Reference Number: EMA/746314/2018

Draft guideline on the clinical evaluation of medicinal products indicated for the prophylaxis or treatment of respiratory syncytial virus (RSV) disease - First version

Consultation dates: 30/10/2017 to 01/05/2018Draft: consultation closedReference Number: EMA/CHMP/257022/2017Summary:

The guideline covers the clinical development of vaccines and monoclonal antibodies for the prevention of RSV disease and direct acting antiviral agents for the treatment of RSV disease. The focus is on the assessment of safety and efficacy in populations most likely to develop RSV lower respiratory tract infection and severe RSV disease, including (newborn) infants and toddlers, older children predisposed to develop severe RSV disease and the elderly. The guideline also addresses vaccination of pregnant women with the aim of preventing RSV disease in their infants. The draft guideline proposes some considerations on nonclinical investigations of efficacy and risk of vaccine-associated enhanced disease to support clinical trials with preventive or therapeutic products directed at RSV.

Concept paper on preparation of a guideline on the evaluation of medicinal products indicated for the treatment and prophylaxis of respiratory syncytial virus (RSV) infection - First version

Summary:

This concept paper proposes the development of a guideline on the clinical evaluation of medicinal products indicated for the treatment and prophylaxis of respiratory syncytial virus (RSV) infections for which there is no regulatory guidance currently available in the EU.