First Drug Approved by FDA to Prevent Premature Births

Premature birth is the leading cause of death among newborns. According to the Centers of Disease Control and Prevention: "More than a half million babies in the United States - that's 1 in every 8 - are born premature each year." Babies born premature ("or less 37 weeks - full term is about 40 weeks") risk short term and long term serious health concerns (Including lung problems and learning disabilities. 2), requiring intensive special care. Premature births may be necessary when the mother's life or health is in jeopardy. Notable risk factors increase premature births: Cigarette smoking, alcohol, illicit drug use, previous premature birth, carrying more than one baby, genetics and problem with the cervix or uterus. 1 In February 2011, the Food and Drug Administration approved a Makena (progesterone injection): Reduce the risk of premature birth in women that had pre-term deliveries. 2

Hologic (Developer & manufacturer of diagnostic technology for women's healthcare - Bedford, Massachusetts - 3) developed Makena: Prevent pre-term births. 4 In January 2010, KV Pharmaceutical Corporation agreed to pay a total of $120 million (Initial payment of $70 million) to Hologic for the drug Makena (Previously referred to as Gestiva). In January 2008, KV Pharmaceutical planned to buy the rights to Gestiva however the agreement was changed, when the FDA did not approve the drug. The amended approved agreement sold the rights of Makena to KV Pharmaceutical Corporation. 5 Makena (trademarked hyproxyprogesterone caproate injection prevent pre-term births, 250 mg/mL. 5) is a synthetic type of progesterone, produced naturally as a hormone during pregnancy. 4 In February 2011, the Food and Drug Administration approved the drug Makena diminish the risk for premature delivery, only for women carrying a single fetus. 6 Deputy Director of the Office of New Drugs in the FDA's Center for Drug Evaluation Research Sandra Kweder, M.D. said: "This is the first drug approved by the FDA that is indicated to specifically reduce this risk (pre-term birth)." 8 However, the FDA required the drug-maker conduct further studies to prove the efficacy of the drug's treatment. 6

Before pre-term contractions Makena is administered, recommend starting between 16 and 21 weeks.
Dr. Errol R. Norwitz, chair of obstetrics and gynecology at Tufts Medical Center said: "We can't stop the uterus once it's gone into labor." During a clinical trial of 463 pregnant (16 to 43 years old 8) women, had a history of spontaneous preterm birth, received weekly injections of Makena (starting 16 - 21 weeks): Thirty-Seven Percent of the control group delivered prematurely, and fifty-five percent had normal pregnancies. "Unfortunately, though Makena (hydroxyprogesterone caproate) isn't a cure-all for preterm birth." Common side effects of the drug include hives, nausea, diarrhea, and itching in the injection site, and pain. The drug rarely causes a blood clot in the lungs and infection at the injection site. The Food and Drug Administration took eight years to approve Makena: Required follow-up data confirming children born to women who were administered Makena developed healthy, from birth to 2.5 years and five years of age. 2 Currently a long-term follow-up study due to be completed in 2018: Evaluating 580 - 750 infants born to women taking Makena. 8

Makena will be available through physicians and specialty pharmacies according to the drug manufacturer representative. Dr. Alan Fleischman, medical director of the March of Dimes said regarding the cost of purchasing Makena: "it is not going to be cheap. This is an orphan drug with a long period of development and a small number of eligible patients. But the drug company has committed itself to making sure every eligible woman has access to the drug." 7

References:

1.) Premature Birth - http://www.cdc.gov/Features/PrematureBirth/

2.) FDA approves first drug to halt premature birth - http://www.boston.com/lifestyle/health/blog/dailydose/2011/02/fda_approves_ne.html

3.) Hologic - http://en.wikipedia.org/wiki/Hologic

4.) FDA clears the runway for KV Pharmaceutical - http://www.stltoday.com/business/local/5c9f1174-3076-11e0-8d79-0017a4a78c22.html

5.) KV's Gestiva resubmitted to FDA - http://www.bizjournals.com/stlouis/stories/2010/07/12/daily36.html

6.) FDA approves premature-birth drug - http://www.philly.com/philly/health_and_science/20110205_FDA_approves_premature-birth_drug.html

7.) FDA approves drug to reduce risk of premature births - http://www.latimes.com/news/la-he-fda-makena-20110205,0,1290916.story?track=rss

8.) FDA Approves Drug to Reduce Risk of Preterm Birth In At-Risk Pregnant Women - http://www.medicalnewstoday.com/articles/215770.php