After years of research shown that the fast-tracked treatment had been unsuccessful in preventing preterm deliveries, an advisory group for the Food and Drug Administration (FDA) recommended on Wednesday that the drug Makena be removed from the market.
Makena has been on the market for the last 11 years, and the decision of the panel was largely seen as a test of the agency’s “accelerated approval” programme, which has helped bring almost 300 promising pharmaceuticals to market in the past 30 years. The programme has been criticised for allowing numerous medications to continue to be used even while follow-up studies are taking an excessively long time to assess whether or not they are effective. The initiative has come under severe scrutiny because to the approval of the Alzheimer’s treatment Aduhelm in the previous year. Aduhelm is an expensive medication that many industry professionals perceive to be untested.
Emotional appeals, concerns of race and health inequity, and other topics have played a role in the decision to remove Makena off the market. Makena is the only medicine that has been authorised to prevent premature delivery. Covis Pharma, the drug’s producer, had made this issue a central focus of its long argument before the Food and Drug Administration (FDA), arguing that the risk of premature delivery is significantly increased for women of African descent.
Wednesday was a busy day for the advisory committee, as they had to weigh in on three distinct votes. The extensive post-market study of the medication did not reveal any benefits to infants, as the panel’s 15 members who participated in the vote all agreed. Thirteen also agreed that the medicine had not been shown to be beneficial in lowering the risk of preterm delivery in female patients who had previously given birth prematurely. Fourteen were in favour of taking the medicine off the market and removing it from circulation.
In 2011, the FDA granted conditional approval to the drug Makena on the grounds that it seemed to assist pregnant women in carrying their babies to full term, which is a factor that is believed to minimise the risk of infant mortality and handicap. According to the firm, there have been 350,000 women in the United States who have used it in the last decade. Following many years of further research, it was shown that the medicine did not help neonates any more than a placebo.
After a loss of this magnitude, pharmaceutical companies would often discreetly pull a product off the market. But Covis Pharma, which is controlled by the private equity firm Apollo Global Management, pleaded with the FDA to let it keep the treatment on the market for a restricted population of high-risk women. In exchange, the company promised to cease advertising the drug and to carry out one more research.
After the vote, Francesco Tallarico, the head counsel for Covis, said that the organisation will provide the agency with new material. He said that it was too early to tell whether the business will pursue additional investigation of the medicine since it was too soon.
This week, agency officials faced off against Covis at a hearing that lasted for three days. They cited their change from optimism to disappointment that the medicine would benefit newborns who were at danger of death or permanent health issues. Covis argued that the drug would not aid babies.
The Food and Medicine Administration (FDA) said in a report that was prepared for the court that failure to remove the drug “would be a disservice to patients” who were at risk for preterm delivery “and would undermine the rapid approval process.” The regulatory body also pointed out that the medication was associated with an increased risk of developing blood clots, depression, and allergic reactions.
Dr. Washington Hill, a Black maternal-fetal expert in Florida, was one among the individuals who testified in support of Covis’s appeal. Other witnesses included: After the voting, Dr. Hill said that he had hoped for a better outcome, but he did see one positive: the panellists unanimously recognised the tremendous need for the high-risk “Black, brown, and vulnerable” patients to have an effective therapy.
According to Dr. Hill, physicians only have treatments for certain subgroups of women who have had a preterm delivery since there is no medication that has been authorised for the condition. According to him, they are also able to recommend bed rest; nevertheless, there is little proof that it is effective.
Before the hearing, the National Association of African American Cops (NAACP) also weighed in on the issue by penning a letter in which it urged advisors to heed the warnings of other advocacy groups that stated that the removal of the drug could “deepen profound existing maternal and infant health inequities in the United States.”
The hearing has been frequently likened to another one that took place in 2011, at which time advisors deliberated on whether or not to continue selling the medicine Avastin as a treatment for breast cancer. It was also authorised via a faster process, despite the fact that a subsequent research revealed the medicine constituted a danger while offering very little benefit. Despite this, a room full of women who had taken the medicine and beat their cancer after taking it filled with applause as they made passionate appeals to the government to keep it on the market.
According to Dr. Aaron Kesselheim, a physician at Harvard who has conducted research on the programme, the decisive advisory vote on Makena highlights why Congress should follow through with giving the F.D.A. more authority to expedite follow-up studies and remove drugs from the market if they come up short. This would allow the FDA to remove drugs from the market if they come up short.