Navigation Links
AstraZeneca submits an sNDA for Symbicort for treatment of asthma in children as young as 6
Date:6/4/2008

Wilmington, DE June 4, 2008 AstraZeneca (NYSE: AZN) today announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the long-term maintenance treatment of asthma in pediatric patients ages 6 to 11 years old. SYMBICORT is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older.

"Millions of children in the U.S. are affected by asthma1," said lead investigator Jeffrey Leflein, MD, Allergy & Immunology Associates of Ann Arbor, Michigan. "SYMBICORT could potentially offer another treatment option for the long-term maintenance of asthma in young children whose condition is not adequately controlled with inhaled corticosteroids alone."

The submission package is based on a robust clinical development program consisting of five active or placebo-controlled Phase III trials assessing the efficacy and safety of SYMBICORT pressurized metered-dose inhaler (pMDI) that included 1,446 children ages 6 to 11 years old with asthma.2 The proposed starting dose for children (80/9 mcg twice-daily) was studied in one pivotal randomized, double-blind, active-controlled, 12-week study that evaluated 256 children ages 6 to 11 years old with mild-to-moderate persistent asthma previously treated with inhaled corticosteroid therapy.3 In this study, SYMBICORT was compared to budesonide pMDI and formoterol dry powder inhaler.3 A second study evaluating this dose included 351 subjects ages 6 to 11 years old.4 Results from both studies demonstrated that SYMBICORT 80/9 mcg twice daily had a similar safety profile to one of the mono-components, budesonide;4,5 likewise, results from the first study also found that SYMBICORT 80/9 mcg twice daily had a similar safety profile to its other mono-component, formoterol.5 The most common adverse events reported were headache, pyrexia, upper respiratory tract infection, nasopharyngitis, and pharyngolaryngeal pain.2

"This sNDA submission is another important milestone for SYMBICORT, and we look forward to discussions with the FDA about the potential indication for children," said Howard Hutchinson, Chief Medical Officer, AstraZeneca. "AstraZeneca remains committed to advancing the treatment of asthma in adult and pediatric patients."


'/>"/>

Contact: Katie Neff
katie.neff@astrazeneca.com
302-885-9960
Edelman Public Relations
Source:Eurekalert

Related medicine news :

1. FDA Approves AstraZenecas Seroquel(R) for Maintenance Treatment in Bipolar Disorder
2. A Drug That Carries a Lower Risk of Weight Gain Than AstraZenecas Seroquel and Has Antimanic and Antidepressant Effects Would Earn a 30 Percent Patient Share in Bipolar Disorder Treatment
3. Washington University in St. Louis and AstraZeneca Announce Alzheimers Research Collaboration
4. Solcara Helps AstraZeneca Set International Benchmark for Global Media Relations
5. AstraZeneca Gives $1.5 million to Support North Carolina Worksite Wellness Project
6. AstraZeneca - Biologics Day Interviews With Senior Management
7. AstraZeneca Receives Six Months Pediatric Exclusivity Patent Extension for ARIMIDEX(R) (anastrozole) from the FDA
8. AstraZeneca Response to November 2, 2007 Ruling In Re: Pharmaceutical Industry Average Wholesale Price Litigation, MDL No. 1456, U.S. District Court, District of Massachusetts
9. Perrigo Announces that Dexcels Settlement with AstraZeneca Allows OTC Omeprazole Launch Following Final FDA Approval
10. Everett-Area Cancer Patients Can More Easily Navigate Health Care System Thanks to the American Cancer Society and AstraZeneca
11. NPS Sells Assets Related to mGluR Collaboration to AstraZeneca for $30 Million to Support Late-Stage Product Development
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/12/2017)... Del. (PRWEB) , ... October 12, 2017 , ... ... and advisory services for healthcare compliance program management, will showcase a range of ... National Association for Assisted Living (NCAL) Convention and Expo to be held October ...
(Date:10/12/2017)... ... October 12, 2017 , ... IsoComforter, Inc. ( https://isocomforter.com ... introduction of an innovative new design of the shoulder pad. The shoulder pad ... comfort while controlling your pain while using cold therapy. By utilizing ice and water ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... Hair Restoration, has recently contributed a medical article to the newly revamped ... Dr. Mohebi’s article spotlights the hair transplant procedure known as Follicular Unit ...
(Date:10/12/2017)... ... 12, 2017 , ... Women-owned and Grand Rapids-based workplace wellness ... in Wellness® by Best and Brightest. OnSite Wellness will be honored at the ... 7:30 a.m. to 2 p.m. at the Henry Autograph Collection Hotel, located at ...
(Date:10/12/2017)... ... October 12, 2017 , ... Farm Forward ... and other leading institutions in announcing the launch of the Leadership Circle ... way animals are raised for food. , Founding members of the Leadership Circle ...
Breaking Medicine News(10 mins):
(Date:9/28/2017)... 2017 Hill-Rom Holdings, Inc. (NYSE: HRC), will ... and webcast on Friday, November 3, 2017, beginning at ... at approximately 8:30 a.m. (CDT) / 9:30 a.m. (EDT). ... financial performance and guidance for 2018, Hill-Rom executives will ... operational performance, and long-range financial outlook through 2020. ...
(Date:9/27/2017)... Sept. 27, 2017  DarioHealth Corp. (NASDAQ: DRIO), a leading global digital ... its MyDario product is expected to appear on The Dr. Oz Show ... Oz Show airs in your area: http://www.doctoroz.com/page/where-watch-dr-oz-show ... The nine-time Emmy award-winning, The Dr. Oz Show kicked off ... The segment features ...
(Date:9/23/2017)... Sept. 22, 2017 Janssen Biotech, Inc. (Janssen) ... letter from the U.S. Food and Drug Administration (FDA) ... sirukumab for the treatment of moderately to severely active ... clinical data are needed to further evaluate the safety ... active RA. ...
Breaking Medicine Technology: