Navigation Links
Pivotal Trial Results for Motavizumab Published in Current Issue of 'Pediatrics'
Date:1/29/2010

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 (LSE: AZN.L, NYSE: AZN), 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

RELATED LINKS
http://www.medimmune.com

'/>"/>

SOURCE MedImmune
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Cephalon Announces Positive Results from a Pivotal Study of FENTORA in Opioid-tolerant Patients with Non-cancer Breakthrough Pain
2. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
3. Positive Kuvan(TM) Pivotal Phase 3 Trial Results Published in The Lancet
4. Genzyme Announces Second Pivotal Mozobil Trial Meets Primary Endpoint
5. Acura Pharmaceuticals, Inc. Secures Financing to Fund Pivotal Phase III Clinical Trial for Lead Aversion(R) Technology Product Candidate
6. CryoCor Completes Enrollment of Pivotal Clinical Study for Atrial Fibrillation
7. Cadence Pharmaceuticals Completes Enrollment of Pivotal Phase III Trial for Intravenous Acetaminophen Ahead of Schedule
8. Kosan Receives Completed Special Protocol Assessment for TIME-1 Pivotal Phase 3 Trial of Tanespimycin in Multiple Myeloma
9. Sucampo Pharmaceuticals, Inc. Begins Pivotal Phase III Studies of Oral Lubiprostone to Treat Opioid-Induced Bowel Dysfunction (OBD)
10. Interim Response and Safety Analyses Support Continuation of Allos Therapeutics Pivotal Phase 2 PROPEL Trial of PDX in Patients with Peripheral T-Cell Lymphoma
11. Arbios Provides Clinical Strategy for SEPET(TM) Pivotal Trial
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/14/2017)... HAMPTON, Va. , June 14, 2017  ivWatch ... safety and effectiveness of intravenous (IV) therapy, is pleased ... in the category of Nonsurgical Hospital Supplies and Equipment ... premier awards program for the medtech industry. The award ... at the Jacob K. Javits Center in ...
(Date:6/11/2017)... INDIANAPOLIS , June 10, 2017  Eli Lilly and ... results from three Phase 3 studies of galcanezumab, an ... migraine, including late-breaking data on several key secondary endpoints ... Detailed results from these studies (EVOLVE-1, EVOLVE-2 and REGAIN) ... (AHS) annual scientific meeting in Boston ...
(Date:6/8/2017)...   Responding to Heath Ledger,s father,s recent ... singer Chris Cornell in May, the mental health ... free online psychiatric drug side effects search ... psychotropic drug risks. The father of the ... accidental overdose, has called for tighter rules on prescription drugs. ...
Breaking Medicine Technology:
(Date:6/23/2017)... ... ... Ulster University, Magee Campus in Northern Ireland is hosting The Schools for ... to graduate students exciting new and innovative hope research based on iFred’s “Schools for ... Improvement Service of the Western Health & Social Care Trust (WHSCT) in partnership with ...
(Date:6/23/2017)... ... June 23, 2017 , ... Jusino Insurance Services, a ... in the greater Chicago metropolitan area, is embarking on a charity drive in ... Chicago. , Founded in 1897, Hephzibah Children’s Association is one of the oldest ...
(Date:6/23/2017)... WV (PRWEB) , ... June 23, 2017 , ... ... protection services and personal financial planning to families and business owners in North ... Stones organization to help provide services to differently abled residents in the region. ...
(Date:6/22/2017)... ... 2017 , ... Branches, Inc. has been partnering with The Miami Foundation for ... its programs focused on providing opportunity to low-income families and breaking the cycle of ... of $15,000 to support its , Climb to College & Career initiative which focuses ...
(Date:6/22/2017)... ... June 22, 2017 , ... United Benefit Advisors (UBA), the ... Company as its newest Partner Firm. Headquartered in Coconut Creek, Florida, Whipple & ... tailoring optimized benefit packages that strengthen the relationship between employer and employee. , ...
Breaking Medicine News(10 mins):