Written and medically reviewed by Dorcas Morak, PharmDCovis has decided to remove its preterm birth drug, Makena, from the market after it was found to be ineffective for both mothers and newborns. Despite being the only available drug to prevent preterm birth, Makena failed to convince two independent advisory committees of its benefits. The drug had enjoyed annual revenue growth from 2011, peaking at $387 million in 2017, but after two years of intense scrutiny, its annual revenue decreased to $122 million. If you are currently taking Makena, you should speak to your healthcare provider as the drug is no longer approved for preventing premature delivery.
What is Makena?
Makena is a brand of hydroxyprogesterone caproate, a synthetic progesterone used to reduce the risk of premature delivery in women who have had one premature baby. However, it will not stop premature labor that has already begun. In 2011, the FDA granted Makena accelerated approval based on the lack of licensed medicines for preterm birth prevention and the potential benefits of early patient access to treatment.
Can healthcare providers still prescribe Makena?
Although the FDA has withdrawn its approval of Makena, a limited number of these medications have already been supplied to some doctors' offices and pharmacies. Medical professionals may still prescribe Makena, but the FDA advises them to consider the drug's ineffectiveness to the approved indication and the potential risks.
Why did FDA withdraw approval of Makena and its generics?
The FDA originally granted accelerated approval to Makena back in 2011 based on a successful trial involving 463 patients which showed that Makena could have a considerable public health effect by reducing the risk of premature birth. At the time, there were no other licensed medicines for preterm birth prevention, so Makena offered a potential advantage of early patient access to this treatment.
So, what happened? After the initial approval, the sponsor was required to conduct a confirmatory clinical trial that was about four times larger than the trial that supported Makena's approval. Unfortunately, this larger trial did not show that Makena improved the health of babies born to the population of interest, nor did it show that Makena decreased the risk of premature birth. As a result, the FDA made the decision to pull their approval of Makena.
According to the FDA's analysis, the differences in the population between the initial trial and the second, larger trial, such as the mother's race and treatment outside of the U.S., did not account for the differences in results between these two trials. The bottom line is that Makena simply does not show evidence that it works in low, medium, or high-risk groups.
Are there other drugs approved for the same indication as Makena?
No. There are currently no other drugs approved to prevent preterm birth.