Navigation Links
March of Dimes welcomes FDA approval of progesterone injections
Date:2/4/2011

WHITE PLAINS, NY, Feb. 4, 2011 The first-ever drug known to prevent some preterm births, which won market approval today from the Food and Drug Administration, was welcomed by the March of Dimes.

"For the first time, we have an FDA-approved treatment to offer women who have delivered a baby too soon, giving them hope that their next child will have a better chance at a healthy start in life," said Alan Fleischman, MD, senior vice president and medical director of the March of Dimes. "Women who already have had a baby born prematurely should check with their health care provider to see if this treatment is appropriate for them. This treatment is not for everyone."

The FDA approved hydroxyprogesterone caproate injection, commonly known as 17P, which is a synthetic form of a hormone produced during pregnancy. It will be marketed under the brand name Makena and given in weekly injections to pregnant women between 16 and 20 weeks gestation and continuing until 37 weeks gestation.

A published study by the March of Dimes, the National Institutes for Health, and the Centers for Disease Control and Prevention, using data from 2002, estimated that if all women eligible for the progesterone injections received them, nearly 10,000 spontaneous premature births might be prevented each year.

Nikki and Densel Fleming's first child, Lauren, was born 3 months early, weighing only two pounds, one ounce. Lauren was hospitalized for five months, a scary and agonizing time for the Marvin, N.C. couple. Although they wanted a bigger family, the Flemings knew Lauren's early birth increased the chance that future babies also would be born too soon. Nikki received weekly progesterone injections for her next two pregnancies and their next two children, Erin and Corbin, were born nearly full term.

"I thank the March of Dimes for making high-risk pregnant women aware of progesterone treatments because, in my heart, I know that the weekly injections I received while pregnant, combined with the knowledge doctors now have about the causes and signs of preterm labor, helped Erin and Corbin be born full term," said Nikki Fleming.

Since 2003, the American Congress of Obstetricians and Gynecologists has recommended that doctors offer progesterone treatments to high-risk women.

Prior to today's approval of Makena, health care providers ordered prescriptions of 17P from compounding pharmacies; however, many eligible patients faced logistical and financial barriers to access. FDA approval means the drug now will be widely available only in specialty pharmacies and that there will be improved access of the drug through healthcare coverage.

The drug is approved for use by women pregnant with one baby and who already have a baby who was born before 37 weeks of pregnancy either because labor began on its own, without drugs or other methods, or because the membranes surrounding the baby ruptured too early.

In the United States, more than half a million babies are born preterm each year. Preterm birth, birth before 37 weeks of pregnancy, is a serious health problem that costs the United States more than $26 billion annually, according to the Institute of Medicine. It is the leading cause of newborn death, and babies who survive an early birth often face the risk of lifetime health challenges, such as breathing problems, cerebral palsy, intellectual disabilities and others. Even infants born just a few weeks early have higher rates of hospitalization and illness than full-term infants. The last few weeks of pregnancy are critical to a baby's health because many important organs, including the brain and lungs, are not completely developed until then.


'/>"/>

Contact: Elizabeth Lynch
elynch@marchofdimes.com
914-997-4286
March of Dimes Foundation
Source:Eurekalert

Related biology news :

1. Press registration opens for American Chemical Society National Meeting, March 27-31, 2011
2. Valencia, Spain to host 2 major bone meetings in March 2011
3. Sanger, Persaud, Marchase receive highest honors from anatomy society
4. Understanding Climates Influence on Human Evolution -- March 31 public event
5. Dian Donnai receives lifetime award in genetics from March of Dimes
6. DOE Joint Genome Institute 5th Annual Meeting on March 24-26, 2010
7. Physics press conferences at next weeks American Physical Society March Meeting
8. 2010 Central Gulf of Mexico Hurricane Conference, Baton Rouge, March 16-17
9. March of Dimes provides $2.6 million in new funding for preterm birth research
10. March of Dimes awards $250,000 prize to scientist who discovered how to reprogram human cells
11. Rapacious Rasberry ants march north
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/20/2016)... Securus Technologies, a leading provider of ... safety, investigation, corrections and monitoring announced that after ... secured the final acceptance by all three (3) ... Systems (MAS) installed. Furthermore, Securus will have contracts ... by October, 2016. MAS distinguishes between legitimate wireless ...
(Date:6/15/2016)... ALBANY, New York , June 15, 2016 ... published a new market report titled "Gesture Recognition Market ... Trends and Forecast, 2016 - 2024". According to the ... at USD 11.60 billion in 2015 and is ... and reach USD 48.56 billion by 2024.  ...
(Date:6/9/2016)... -- Paris Police Prefecture ... to ensure the safety of people and operations in several ... tournament Teleste, an international technology group specialised in ... that its video security solution will be utilised by ... safety across the country. The system roll-out is scheduled for ...
Breaking Biology News(10 mins):
(Date:6/23/2016)... June 23, 2016 /PRNewswire/ - FACIT has announced ... biotechnology company, Propellon Therapeutics Inc. ("Propellon" ... commercialization of a portfolio of first-in-class WDR5 inhibitors ... such as WDR5 represent an exciting class of ... precision medicine for cancer patients. Substantial advances have ...
(Date:6/23/2016)... YORK , June, 23, 2016  The Biodesign ... to envision new ways to harness living systems and ... Modern Art (MoMA) in New York City ... than 130 participating students, showcased projects at MoMA,s Celeste ... Paola Antonelli , MoMA,s senior curator of architecture ...
(Date:6/23/2016)... , June 23, 2016 Apellis ... Phase 1 clinical trials of its complement C3 ... single and multiple ascending dose studies designed to ... (PD) of subcutaneous injection in healthy adult volunteers. ... (SC) either as a single dose (ranging from ...
(Date:6/23/2016)... ... June 23, 2016 , ... ... and technical consulting, provides a free webinar on Performing Quality Investigations: ... 2016 at 12pm CT at no charge. , Incomplete investigations are still a ...
Breaking Biology Technology: