FDA Panel Recommends Withdrawing Drug to Prevent Preterm Births

Pre-term baby's hand holds finger of an adult

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The Food and Drug Administration (FDA) says a drug aimed at preventing preterm births should be pulled from the market. That's because a key advisory committee found the drug to be ineffective. But this decision does not come without some controversy.

In October 2022, the FDA held a hearing about a drug produced by Swiss pharmaceutical company Covis, called Makena. The FDA's Obstetrics, Reproductive, and Urologic Drugs Advisory Committee heard testimony surrounding the medication. Ultimately, the members recommended withdrawing Makena from the market. A final decision from the FDA is expected by the end of the year.

However, critics argue Makena's removal from the marketplace will negatively impact high-risk populations and deepen health inequalities. This has the potential to change the landscape of obstetric medicine.

What is the Drug Makena Used For?

Makena is an injectable drug meant to prevent preterm labor of singleton babies in a second pregnancy. It was initially fast-tracked through approval in 2011 by the Center for Drug Evaluation and Research (CDER), an arm of the FDA. The FDA accelerated its approval in order to get it to the market quicker. Officials noted that Makena was being used to treat a serious condition, and at the time, it provided an advantage over other treatments.

Preterm Birth in the U.S.

  • The Centers for Disease Control and Prevention (CDC) defines preterm birth as when a baby is born before 37 weeks of pregnancy.
  • Preterm birth affected 1 out of every 10 infants born in 2020. The preterm birth rate declined by .1%, between 2019 and 2020 to 10.1%.
  • However, the preterm birth rate among African-American birthing people was significantly higher than the national average, at 14.4%. That's also about 50% higher than among White or Hispanic birthing people.
  • In CDER's Makena trial, approximately 60% of those birthing people enrolled identified as Black; however, the FDA explains the drug is neither more nor less effective in Black birthing people.

Why Do Advisors Want to Remove Makena From the Market?

Makena's initial approval hinged on a study conducted in 2011. That trial suggested the drug reduced preterm labor in people who had a previous unexplained preterm birth. As a condition of the fast-tracked approval, Covis Pharma had to move forward with clinical trials to confirm that finding. The company also had to show it also improved the health of babies born to people who had a previous preterm birth.

In their last international trial, the FDA found that Makena's effectiveness was lower than expected. It did not show improvement in the health of those children born to parents who were treated with the drug. Further, the trial did not demonstrate Makena's effectiveness to reduce preterm birth at all.

"The committee found that the body of current evidence did not support continuing the accelerated approval of Makena for the prevention of recurrent preterm birth in anyone with a history of a prior spontaneous preterm birth between 20 and 37 weeks," says Anjali Kaimal, MD, a maternal-fetal specialist who was invited by the FDA committee to testify hearing.

Because of conflicting information over the effectiveness of the drug, the FDA panel proposed to withdraw Makena from the market, as well as its generic equivalents.

"Obstetric literature suggests that spontaneous preterm birth likely has many causes, so it may be that some people could benefit from Makena, but the evidence to this point does not clearly indicate who that population is. The consensus was that additional research was needed," Dr. Kaimal says.

Makena will remain on the market pending the FDA's final decision. But FDA advisers recommend doctors review the committee's findings, speak with their patients, and report any adverse responses to the medication.

How Does Removing Makena Affect Pregnant People?

With Makena's removal, there would be no medication on the market to treat preterm births.

"There are very few FDA-approved medications for any pregnancy complications. This reflects the fact that pregnant people are an understudied population," Dr. Kaimal says. "Not having products on the market does not mean that there are no evidence-based interventions for the treatment of pregnant people. Our professional societies provide guidance regarding evidence-based practices."

Dr. Kaimal cited groups like the American College of Obstetricians and Gynecologists and the Society for Maternal-Fetal Medicine to help guide the treatment of pregnant people.

Covis Pharma stands by its product. "As presented during the hearing, we believe that Makena is effective in a higher-risk patient population," Raghav Chari, PhD, chief innovation officer at Covis Pharma says in a statement.

In the initial accelerated study to gain Makena's market approval in the United States, the majority of responders were people of color with high-risk pregnancies. However, the committee's subsequent trial did not indicate a higher efficacy for people of color over any other targeted demographic. With the removal of Makena from the market, BIPOC families may find themselves without support, especially if no other medication is developed.

Covis Pharma's stance on the medication as beneficial for high-risk patient populations while pointing to their initial study is controversial. Critics are pushing back on the company using its own study in efforts to keep the medication on the market. 

"Black birthing people experience a high rate of spontaneous preterm birth in addition to other maternal and neonatal morbidity and mortality, but offering a medication not shown to be effective is not going to help to solve that concern," Dr. Kaimal explains. "[It] may be a barrier to investigating other potentially effective interventions."

What's Next for Makena?

Despite the committee's suggestion, the FDA still needs to weigh in on the recommendation with a final decision. Covis Pharma is allowed to continue distributing Makena, as well as test it independently. Doctors may also continue prescribing the medication to their patients. In the coming months, doctors and patients alike may look forward to more information from the FDA concerning Makena's continued availability and effectiveness.

What This Means For You

A key FDA panel is recommending pulling a medication meant to treat preterm births from the market. The experts found Makena to be ineffective—although it is the only treatment available on the market. High-risk populations and people of color may feel this potential removal disproportionately. Talk to your healthcare provider if you are currently taking Makena to assess your risks.

4 Sources
Verywell Family uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. FDA. Makena - Frequently Asked Questions.

  2. Centers for Disease Control. Preterm Birth.

  3. Food and Drug Administration. CDER Proposes Withdrawal of Approval for Makena.

  4. Covis Pharma. Covis Pharma Reports on FDA Advisory Committee Hearing for Makena®

By Taylor Grothe
Taylor is a freelance writer, fiction author, and a nonbinary parent to two little children, ages five and three. Their fiction work can be found in Bag of Bones Press and Coffin Bell Journal, and their first novel is on submission to major publishing houses.