Drug to Prevent Premature Birth Divides Doctors, Insurers And FDA ExpertsNPR #Preterm_BirthJanuary 24, 2020
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Doctors fear that the only drug approved to prevent preterm birth, the nation’s leading cause of infant mortality and disability, will no longer be available to expectant mothers.
Doctors are torn between two clinical studies of the drug that had differing results: An older trial of American patients at high-risk of having a pre-term delivery showed Makena’s active ingredient seemed to be effective.
The drug seemed so clearly effective in that research that researchers ended the study early.
In 2017, a study of the drug’s cost by researchers from Harvard University found no notable difference between the outcomes of women who took Makena and women who took compounded 17P — even though the mean per-pregnancy cost of Makena was $10,711 more than 17P.
But compounding of 17P continued until 2016, when the FDA approved a preservative-free version of Makena and, in doing so, handed AMAG Pharmaceuticals the exclusive right to make the drug, ending the compounding of 17P.
For years, the results of the NIH’s 2003 study reassured many doctors, insurers, health officials and patients: 17P, Makena’s active ingredient, had been proven to prevent preterm birth.
But while the FDA granted it approval to market Makena, the agency also ordered the company to conduct its own trial to confirm it was safe and effective, though with stricter requirements: Among other things, the company would have to prove the drug was effective at preventing preterm birth before 35 weeks, rather than 37.
For one thing, 35% of participants in the NIH trial had experienced preterm birth more than once, putting them at higher risk, compared with just 15% in AMAG’s trial.
Based largely on AMAG’s findings, the FDA’s expert panel recommended in October, in a 9-7 vote, that the FDA withdraw its approval of Makena.
As doctors stand by for the FDA’s decision on withdrawing Makena from the market, many have suggested they will turn to compounding again, if Makena disappears.
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