Despite requests from the manufacturer to keep the injectable pregnancy drug Makena available pending more research, the Food and Drug Administration advisory panel decided 14-1 that it should be withdrawn.
Washington: Federal health advisers have determined that a drug intended to prevent preterm births hasn’t been proven effective, paving the way for American regulators to finally take action to take it off the market after a protracted delay.
Despite requests from the manufacturer to keep it available pending further research, the Food and Drug Administration advisory panel decided 14-1 on Wednesday that the injectable medication Makena should be discontinued.
In general, the experts supported an FDA decision from 2020 that declared the drug ineffective and demanded its removal. Covis Pharma’s manufacturer had contested that ruling, leading to the unusual public hearing this week.
Obstetrics expert Dr. Margery Gass stated, “If we permit Makena to remain on the market, it implies the FDA looked at a significant study, found no benefit, and yet allowed this drug to remain on the market. I believe that sets a bad example.”
Clovis was urged to conduct more research on the drug to see if a subgroup of women could benefit from Gass and the other panelists.
Dr. Mary Munn of the University of South Alabama stated, “I do think that our patients deserve an answer and they deserve that well-designed clinical trial, and I think that taking the drug off the market is going to allow that.”
In the upcoming months, FDA Commissioner Dr. Robert Califf is anticipated to make a final decision regarding the drug’s withdrawal. If he follows the panel’s recommendations, it will mark the first occasion that the FDA formally withdraws a drug that it had initially approved based on encouraging preliminary data.
Based on a small study that appeared to lower the rate of preterm birth in women with a history of the issue, the FDA granted Makena accelerated approval in 2011. Preterm birth affects 10% of deliveries in the United States and increases the risk of infant death and disability.
A more extensive follow-up study to verify whether Makena led to healthier outcomes for babies was required for the FDA to approve the product.
However, in 2019, an international study involving 1,700 patients revealed the drug neither reduced preterm births, as was initially believed nor produced healthier outcomes for infants.
Since then, the FDA has been working to revoke the drug’s approval. However, the protracted, bureaucratic process highlights how challenging it is to pull a drug off the market when the manufacturer is unwilling to do so voluntarily.
This week, the Luxembourg-based Covis Pharma made the case that Makena helps women at risk for premature birth, including Black Americans, and suggested restricting its approval to that population. At the same time, it carried out a follow-up study to confirm its efficacy. Outside experts who the company in its presentations quoted claimed that getting rid of Makena would worsen racial disparities in prenatal care.
Dr. Yolanda Lawson, an obstetrics specialist at Baylor University, told the FDA panel, “The FDA should do what is best for our patients, which is to keep this medication available for those of us who manage these very high-risk patients every day.”
The FDA scientists, who emphasized that they were “unable to identify a group of women for whom Makena had an effect,” ultimately won the experts’ support. The FDA noted that the medication has additional risks, such as blood clots and depression.
Since the early 1990s, the FDA has come under pressure to take action against unproven drugs launched based on preliminary results after receiving accelerated approval. The program’s opposite involves stopping the use of medications if subsequent research doesn’t support their initial promise.
Since Makena has been available on the market for more than ten years without providing any proven benefits, it has become a symbol of the program’s drawbacks. The United States has spent $700 million on Makena since 2018 through various government programs, including Medicaid, according to a recent federal report.
According to Covis, 350,000 women used the drug in the previous ten years.
Even if the drug is discontinued, some physicians are anticipated to keep prescribing its active ingredient as a specialized drug. For a very long time, compounding pharmacies have provided their drug formulations. The hormone progesterone, which aids in uterine growth and pregnancy maintenance, is present in Makena and the compounded medications.
