Navigation Links
FDA Approves Drug to Reduce Risk of Preterm Birth in At-Risk Pregnant Women
Date:2/4/2011

SILVER SPRING, Md., Feb. 4, 2011 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Makena (hydroxyprogesterone caproate) injection to reduce the risk of preterm delivery before 37 weeks of pregnancy, in pregnant women with a history of at least one spontaneous preterm birth.  

(Logo:  http://photos.prnewswire.com/prnh/20090824/FDALOGO)

The drug is not intended for use in women with a multiple pregnancy, such as a twin pregnancy, or other risk factors for preterm birth.  

The FDA approved Makena under the agency's accelerated approval regulations that allow promising drugs to be approved based on a surrogate endpoint benefit (here, reducing the risk of delivery before 37 weeks of pregnancy) that is reasonably likely to predict a clinical benefit.

Under these regulations, the manufacturer must conduct additional studies after the product is approved to demonstrate that the drug does, in fact, have a clinical benefit.  An international trial is ongoing to learn if there is also improvement in the outcome of babies born to women given Makena. Such outcomes include reducing the number of babies who do not survive or who suffer serious health problems shortly after birth.  

"Preterm birth is a significant public health issue in the United States," said Sandra Kweder, M.D., deputy director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research. "This is the first drug approved by the FDA that is indicated to specifically reduce this risk."

A health care provider would give Makena once a week by injection into the hip. Treatment should begin at 16 weeks and no later than 21 weeks of pregnancy.

The FDA reviewed data on the safety and effectiveness of Makena in a multicenter randomized double-blind clinical trial. The study included 463 women 16 to 43 years of age who were pregnant with a single fetus and had a history of a prior spontaneous preterm birth. Among women treated with Makena, 37 percent delivered early (before 37 weeks) as compared with 55 percent of women in the control group.  

A separate study evaluated the development of children born to mothers enrolled in the controlled trial. In this study, children ages 2.5 years to 5 years reached similar developmental targets, regardless of the mother's treatment.  The confirmatory study that is ongoing will be followed by a similar infant follow-up study, to be completed about 2018.  That study is expected to include 580-750 infants, depending on the number of study sites and mothers willing to participate.  

The most common side effects reported with Makena included pain, swelling, or itching at the injection site; hives, nausea and diarrhea. Serious adverse reactions were rare; there was a single report each of blood clot in the lungs (pulmonary embolism) and an infection at the injection site.

The FDA originally approved hydroxyprogesterone caproate under the trade name Delalutin in 1956 for use in pregnant women. The approved indications include threatened miscarriage. The original manufacturer requested the withdrawal of Delalutin from the market in 2000 for reasons unrelated to safety.

Consumers and health care professionals are encouraged to report adverse events from medications to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/how.htm.

Makena is manufactured by Baxter Pharmaceutical Solutions LLC, based in Bloomington, Ind.

For more information:

Approved Drugs: Questions and Answers

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/UCM054420  

Media Inquiries: Shelly Burgess, 301-796-4651, shelly.burgess@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA




'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. FDA Approves Lillys Osteoporosis Drug EVISTA(R) (raloxifene HCl) to Reduce The Risk of Invasive Breast Cancer in Two Populations of Postmenopausal Women
2. Health Canada Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for HIV
3. FDA Approves Cymbalta(R) for Maintenance Treatment of Major Depressive Disorder
4. European Commission Approves ATRIPLA(R) (efavirenz 600 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg), the First Once-Daily Single Tablet Regimen for Virologically Suppressed Adults With HIV-1 Infection
5. FDA Approves MiddleBrooks Amoxicillin PULSYS for Pharyngitis/Tonsillitis in Adolescents and Adults
6. FDA Approves XYZAL(R) (levocetirizine dihydrochloride) Oral Solution for the Relief of Seasonal and Year Round Allergies and Chronic Idiopathic Urticaria
7. UM Maryland Industrial Partnerships Program Approves 18 Collaborative Research Projects, Worth $4.4 Million, Between University Faculty, State Technology Companies
8. U.S. Food and Drug Administration Approves ABILIFY(R) (aripiprazole) for the Acute Treatment of Manic and Mixed Episodes Associated With Bipolar I Disorder in Pediatric Patients (10 to 17 Years of Age)
9. U.S. Food and Drug Administration Approves ORENCIA(R) (abatacept) for the Treatment of Moderate-to-Severe Polyarticular Juvenile Idiopathic Arthritis (JIA) in Patients Six Years and Older
10. FDA Approves HIFU Clinical Trial for Recurrent Prostate Cancer
11. EPA Approves XDS-CALUX(R) as Alternate Dioxin Test Method 4435
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)...  Zimmer Biomet Holdings, Inc. (NYSE and SIX: ZBH), ... it will be participating in the Deutsche Bank Securities ... in Boston, Massachusetts on Wednesday, ... a.m. Eastern Time. A live webcast of ... Relations website at http://investor.zimmerbiomet.com .  The webcast will ...
(Date:4/20/2017)...  CVS Pharmacy, the retail division of CVS ... design to enhance the retail customer experience with ... and expanded beauty selections paired with informational signage ... offerings. Together with its innovative digital programs, these ... experience at CVS Pharmacy.  "Pharmacy ...
(Date:4/20/2017)... April 20, 2017 Eyevensys, a ... first non-viral gene expression technology that enables the safe, ... to address a wide range of ophthalmic diseases, announces ... Healthcare products Regulatory Agency (MHRA) to advance its technology ... ...
Breaking Medicine Technology:
(Date:4/25/2017)... ... April 25, 2017 , ... Somnoware, a leading provider ... care management module. Using this new feature, sleep physicians can now predict the ... continuous positive airway pressure (CPAP), oral, or other forms of sleep apnea therapy. ...
(Date:4/24/2017)... ... April 24, 2017 , ... Emmanuel College ... nursing professionals advance their careers. Beginning in the fall of 2017, Emmanuel’s program will ... in as few as 16 months and for as little as $14,528. These changes ...
(Date:4/24/2017)... ... 2017 , ... As part of the nationwide Days of Remembrance effort led ... Holocaust and Nazi persecution, Center for Medicine after the Holocaust (CMATH) announced ... trip to Germany and Poland next week. , The Fourth Biennial CMATH Champions Trip ...
(Date:4/24/2017)... ... 2017 , ... Sean Fay is the undisputed king of the infomercial. With ... the George Foreman Grill (which sold more than 100 million units worldwide), he has ... , Now, due to changes in the broadcast media landscape, the once ever-present infomercial ...
(Date:4/24/2017)... ... , ... My T Chai, a South African company that creates a number ... RevNutrition.com, a popular website specializing in sales of nutritional products. , Chai tea ... Siam. It spread across Asia and Africa quickly, and today recipes vary from region ...
Breaking Medicine News(10 mins):