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Drug to prevent premature birth gets accelerated FDA approval

Kathleen Blanchard's picture
Premature birth

The FDA announced accelerated approval of the drug Makena to reduce the risk of premature birth in women who have had at least one preterm delivery.

The drug is injected once a week to lower the chances of delivery before 37 weeks into pregnancy. The FDA accelerated approval of Makena -hydroxyprogesterone caproate - is based on studies showing the medication is "reasonably likely" to provide benefit.

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

The FDA says data from studies show the drug is safe, but under accelerated approval guidelines, ongoing studies will be needed. KV Pharmaceutical/Ther-Rx Corp recently obtained rights to the drug, formerly known as Gestiva.

In a drug trial, Makena was given to 463 women 16 to 43 years of age pregnant with one fetus who had experienced spontaneous premature delivery. In the trial, the drug reduced the number of preterm births to 37 percent with the drug compared to 55 percent in a control group.

In January, the FDA withheld approval of Makena, formerly marketed as Gestiva, pending more information from the manufacturer. In 1956, hydoxyprogesterone caproate was approved under the trade name Delalutin, but was withdrawn by Bristol-Myers Squibb Co, because the company was no longer marketing the drug.

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Makena is given to women at risk for premature birth beginning at 16 weeks and no later than 21 weeks. Side effect reports include localized reaction at the injection site in addition to more generalized side effects of nausea, hives and diarrhea. In the study, there was one report of pulmonary embolism - blood clot to the lung and infection where the drug was injected.

The FDA's accelerated approval of Makena to reduce premature births is supported by the March of Dimes. Alan Fleischman, MD, senior vice president and medical director of the March of Dimes said in a news release, “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."

Makena is a form of the hormone progesterone, also known as 17P. To date, no studies have linked 17P to abnormalities in fetal development.

A May 2007 study, "Cervical length changes during preterm cervical ripening: effects of 17-a-hydroxyprogesterone caproate", published in the American Journal of Obstetrics & Gynecology found the compound in Makena reduced preterm births in women with shortening of the cervix that is a risk for premature delivery.

According to the National Academy of Sciences, premature births cost $26 billion annually. In 2003, 17.8 percent of pregnant black women gave birth to a preterm baby. Infants born prematurely suffer respiratory problems and developmental delays.

Accelerated approval of Makena to prevent premature births for women at high risk is the first and only treatment approved by the FDA for women with a single fetus. The FDA approval follows a review of 2 clinical trials that showed the drug has benefits and caused no harm to infants, though ongoing studies will be required.