Pivotal Trial Results for Motavizumab Published in Current Issue of 'Pediatrics'
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.
The phase 3, pivotal trial assessed the safety and RSV
hospitalization in 6,635 preterm infants aged six months or younger
at enrollment or children aged 24 months or younger with chronic
lung disease of prematurity who received either 15 mg/kg
palivizumab or motavizumab monthly. Secondary endpoints included
outpatient medically attended lower respiratory tract infections
(MALRIs), RSV-specific MALRIs, otitis media, antibiotic use,
development of anti-motavizumab antibodies and motavizumab serum
concentrations.
In this first head-to-head trial, motavizumab demonstrated
non-inferiority, but not superiority, to Synagis®
(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.
In November 2008, the FDA issued a complete response letter
(CRL) to MedImmune seeking clarification on the motavizumab
Biologic License Application (BLA). MedImmune filed its response
with the FDA in December 2009 and continues in its ongoing dialogue
with the agency.
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.
About Synagis
Synagis is the only monoclonal antibody approved by the FDA to
help prevent an infectious disease. Synagis was approved for use in
the United States in 1998, Europe in 1999, and Japan in 2002.
Synagis is currently available in 62 countries.
Synagis® (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.
Common side effects may include fever, cold-like symptoms (upper
respiratory infection) including runny nose and ear infection, and
rash. Other possible side effects include skin reactions around the
area where the shot was given (like redness, swelling, warmth or
discomfort). In children born with certain types of heart disease,
other possible side effects include bluish color of the skin, lips
or under fingernails and abnormal heart rhythms. These are not all
the possible side effects of Synagis.
For full prescribing information for Synagis, see the company's
website at: www.medimmune.com/products/synagis/index.asp.
About MedImmune
MedImmune, the worldwide biologics business for AstraZeneca PLC
, has approximately 3,300 employees worldwide and is headquartered
in Gaithersburg, Maryland. With an advancing pipeline of promising
candidates, we aim to be the next revolutionary force in
biotechnology by delivering life-changing products,
industry-leading performance, and a tireless commitment to
improving patient health. For more information, visit MedImmune's
website at www.medimmune.com.
Source: MedImmune
CONTACT: Tor Constantino, MedImmune, +1-301-398-5801,
constantinos@medimmune.com
Web Site: http://www.medimmune.com/
Posted: January 2010
