dm+d

Unassigned

New Medicines

Respiratory syncytial virus infection in adult and adolescent hematopoietic stem cell transplant (HSCT) recipients

Information

New molecular entity
Janssen-Cilag
Johnson & Johnson

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
Phase II Clinical Trials

Category

Fusion protein inhibitor of the F-glycoprotein-mediated complex membrane fusion process of the RS virus
RSV is a major cause of respiratory viral infection in HCT patients. Determination of the true incidence of RSV infection is challenging, with a reported wide range of 5% to 49%. The proportion causing LRTI ranges from 30% to 60% with lower rates of LRTI (24-44%) since year 2000. The estimated incidence of RSV infections in paediatric HCT recipients is 3% to 7%, with 22%-37% developing LRTI [1].
Respiratory syncytial virus infection in adult and adolescent hematopoietic stem cell transplant (HSCT) recipients
Oral and
Subcutaneous injection

Moderate to severe upper respiratory tract diseases caused by respiratory syncytial virus infection in hospitalised children - oral suspension formulation

Information

Licence extension / variation and new formulation
Janssen-Cilag
Johnson & Johnson

Development and Regulatory status

Phase II Clinical Trials
Phase III Clinical Trials
Phase III Clinical Trials

Category

Fusion protein inhibitor of the F-glycoprotein-mediated complex membrane fusion process of the RS virus. Oral suspension formulation, given twice daily for 7 days.
In the UK, RSV accounts for approximately 450,000 GP appointments, 29,000 hospitalisations and 83 deaths per year in children and adolescents, the majority in infants. It also has a major impact on elderly adults; 175,000 GP appointments, 14,000 hospitalisations and 8,000 deaths per year in the UK [1].
Moderate to severe upper respiratory tract diseases caused by respiratory syncytial virus infection in hospitalised children - oral suspension formulation
Oral