Phase 3 Pivotal Trial Demonstrated 26 Percent Relative Reduction in RSV Hospitalization; 50 Percent Relative Reduction in Incidence of RSV Outpatient Visits
GAITHERSBURG, Md., Jan. 29 /PRNewswire/ -- MedImmune today announced that clinical results of its pivotal multinational, randomized, double-masked trial for motavizumab have been published in the current issue of the peer-reviewed publication, Pediatrics: Official Journal of the American Academy of Pediatrics. Motavizumab is an investigational monoclonal antibody (MAb) being evaluated by the FDA for its potential to prevent serious disease caused by respiratory syncytial virus (RSV) among infants at high risk.
In this first head-to-head trial, motavizumab demonstrated non-inferiority, but not superiority, to Synagis(R) (palivizumab), meeting the primary endpoint with a 26 percent relative reduction in RSV hospitalizations versus Synagis (p<0.01 for non-inferiority) due to RSV. Motavizumab also demonstrated superiority compared to Synagis, with a 50 percent relative reduction in RSV lower respiratory tract infections requiring outpatient management (p=0.005), which was one of the secondary endpoints of the trial. Other secondary endpoints were not statistically significant. Adverse events were similar in both groups, although, motavizumab had two percentage points more adverse events reported for the skin compared to Synagis; the majority were non-specific rashes that did not recur or affect dosing.
About RSV
Each year, up to 125,000 infants in the U.S. are hospitalized with severe RSV infections, the leading cause of lower respiratory tract infections in infants in the United States. RSV is the most common respiratory infection in infancy or childhood. Approximately one-half of all infants are infected with RSV during the first year of life, and nearly all children have been infected at least once by the time they reach their second birthday. Children born prematurely as well as those with chronic lung disease (CLD) or congenital heart disease (CHD) are at highest risk for severe disease and hospitalization due to RSV.
Synagis(R) (palivizumab) is a prescription medication that is used to help prevent a serious lung disease caused by respiratory syncytial virus (RSV) in infants and children at high risk. Synagis is given as a shot, usually in the thigh muscle, each month during the RSV season. Children who develop an RSV infection while receiving Synagis should continue the monthly dosing schedule throughout the season. Synagis should not be used in patients with a history of a severe allergic reaction to Synagis or its ingredients. Cases of severe allergic reactions such as anaphylaxis and other types of hypersensitivity reactions have been reported with Synagis. These reactions may occur when any dose of Synagis is given, not just the first one. Very low platelet counts may occur, which may lead to unusual bruising and/or groups of pinpoint red spots found on the skin.
For full prescribing information for Synagis, see the company's website at: www.medimmune.com/products/synagis/index.asp.
MedImmune
