GAITHERSBURG, Md., Feb. 4 /PRNewswire/ -- MedImmune announced today it
submitted to the U.S. Food & Drug Administration (FDA) on January 30 a
Biologics License Application (BLA) for motavizumab, an investigational
monoclonal antibody (MAb) derived from recombinant DNA technology. The
motavizumab BLA is supported by clinical trial data from more than 6,000
patients in which safety and efficacy in prevention of serious disease caused
by respiratory syncytial virus (RSV) in high-risk pediatric patients were
"We are pleased to submit this BLA for motavizumab, which we believe
represents another tool in the fight against RSV. This marks a significant
milestone for this molecule and further reinforces MedImmune's commitment to
developing anti-RSV biologics for the underserved pediatric patient
population," said Linda J. Peters, senior vice president, regulatory affairs.
Motavizumab was studied in an active-controlled Phase 3 trial against the
standard of care in pediatric patients at high risk of serious RSV disease.
Primary and secondary endpoints of the study included incidence of RSV
hospitalizations and RSV-specific medically attended outpatient lower
respiratory tract infections. Rates of adverse events, serious adverse
events and study drug discontinuations were balanced between treatment groups.
The most frequently observed reactions versus the active comparator were
cutaneous reactions (overall).
"Beyond the findings of the various investigational trials for
motavizumab, we believe this molecule will help reinforce the positive role
that MAbs play in RSV prevention within the current clinical body of evidence.
It also reinforces our position as a leader in RSV prevention," said Genevieve
Losonsky, M.D., vice president, clinical development, infectious disease.
RSV is a leading cause of viral respiratory infection among infants. Each
year, up to an estimated 125,000 infants in the United States are hospitalized
with severe RSV infections, the leading cause of infant hospitalization within
the U.S. 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.
In the United States, RSV causes up to 1.7 million physician office
visits; 400,000 emergency room visits and more than 230,000 hospital
outpatient emergency room visits per year. RSV is the most common respiratory
infection in infancy or childhood. Children born prematurely as well as those
with chronic lung disease (CLD) or congenital heart disease (CHD) are at high
risk for severe disease and hospitalization due to RSV.
RSV infection usually manifests as an upper respiratory tract infection
with symptoms resembling a cold. Preterm infants, those with chronic lung
disease, and infants with complicated cardiac disease are especially
vulnerable to the infection and have an increased risk of progressing to a
serious lower respiratory tract infection that sometimes requires
hospitalization, mechanical ventilation and intensive care.
MedImmune intends to commercialize motavizumab through its existing sales
and marketing organization within the U.S., and to co-promote with Abbott in
certain non-U.S. markets if and when the product is approved for marketing by
regulatory authorities. Outside the U.S., Abbott, the global, broad-based
health care company, has marketing and distribution rights for motavizumab.
MedImmune's Commitment to RSV Prevention
MedImmune is a world leader in the development of innovative therapeutic
biologic products to prevent RSV disease. With the ongoing development of
motavizumab, MedImmune continues to reinforce its commitment to developing
anti-RSV products. MedImmune is also developing a small-molecule product
candidate to prevent RSV as well as a vaccine against RSV, both of which are
in Phase 1 clinical trials.
MedImmune strives to provide better medicines to patients, new medical
options for physicians and rewarding careers to employees. Dedicated to
advancing science and medicine to help people live better lives, the company
is focused on the areas of infectious diseases; cancer; inflammatory diseases;
cardiovascular and metabolic diseases; pain and central nervous system
disorders and gastrointestinal diseases. With approximately 3,000 employees
worldwide and headquarters in Maryland, MedImmune is wholly owned by
AstraZeneca plc (LSE: AZN.L, NYSE: AZN). For more information, visit
MedImmune's website at www.medimmune.com.
CONTACT: Media: Tor Constantino, +1-301-398-5801, Investors: Peter
Vozzo, +1-301-398-4358, both of MedImmune/