As a subscriber, you have 10 gift items to give away every month. Anyone can read what you share. An advisory committee of the Food and Drug Administration (FDA) recommended taking the drug Makena off the market on Wednesday, after years of studies showing that the accelerated drug had failed to prevent premature births. This is the first time in more than a decade that the agency, which normally follows the advice of its expert panels, seems to be about to force a drug manufacturer to stop selling an accelerated product.
The decision to remove Makena from the market, the only drug approved to prevent
preterm birth
, has been mixed with emotional appeal and problems of racial disparity and health. The risk of preterm birth is much higher for black women, a point on which Covis Pharma, the manufacturer of the drug, had long insisted on defending its arguments before the FDA. If the agency follows the panel's recommendation and orders that the drug be removed from the market, patients who have had a premature birth and are facing a second birth would not have an approved treatment (although Covis could continue with studies on the drug). “The situation is devastating,” said Annie Ellis, patient representative on the panel in White Plains, New York.The advisory committee intervened in three separate votes on Wednesday. All 15 members of the voting panel agreed that the long-term post-marketing trial of the drug showed no benefit for infants. Thirteen also agreed that the drug had not been shown to be effective in reducing the risk of preterm birth in women who had already had a preterm birth. Fourteen agreed that the drug should be withdrawn from the market.
After voting in favor of eliminating the drug, Dr. Anjali Kaimal, an obstetrician and administrator at the University of South Florida, admitted that it was “terrifying to tell a patient that there is no treatment for a serious condition”. However, “additional studies are needed”, he said. Usually, drug manufacturers silently recall a drug after such a defeat.
However, Covis Pharma, owned by the private equity firm Apollo Global Management, asked the agency to allow it to keep the drug on the market for a small group of high-risk women, while promising to stop promoting it and conduct another study. He also warned that even if the FDA recalled the drug, it could still be available in pharmacies specializing in compounds, which had a history of sterility and contamination problems. After the vote, Francesco Tallarico, chief lawyer for Covis, said that the company would submit additional information to the agency. He said it was too early to say if the company would conduct further studies on the drug.
During a three-day hearing held this week, agency officials confronted Covis and mentioned that they had gone from hope to disappointment that the drug would help babies at risk of death or lifelong health problems. Robert Califf, the agency's commissioner, will issue a final decision in approximately 90 days. He also intervened before the hearing with a letter urging advisors to pay attention to other advocacy groups that said that withdrawing the drug could “deepen the profound maternal and child health inequalities that exist in the United States”. That hearing was so controversial that members of the advisory committee who voted to withdraw the drug were removed from hearing by security guards and put them on a fleet of black sedans waiting for them.
Margaret Hamburg, then commissioner of FDA finally decided to withdraw approval for use of this drug. Makena's virtual hearing which began on Monday lacked electricity of face-to-face event and handful of women asked agency to study this drug further by teleconference. This year he announced “Confirm Project” which focuses on evaluating fast-track cancer drugs. The decisive consultative vote on Makena underlines why Congress should go ahead with granting FDA more authority to accelerate follow-up studies and remove drugs from market if they aren't enough said Dr Aaron Kesselheim Harvard doctor who has researched program.
Maintaining confidence in program “requires acting quickly in cases like this where initial hope is not enough”. In light of conflicting evidence on effectiveness of this drug and recommendation of expert panel to withdraw this drug from market future of this drug is in limbo as shown in following figure 17OHPC was initially considered effective after trial discovered 34% reduction in incidence of preterm births in treated group. According to Centers for Disease Control and Prevention preterm birth is more common among babies born to black mothers trial found that this drug failed to reduce risk of preterm births or produce better health outcomes for newborns Alan Peaceman director maternal-fetal medicine at Northwestern University's Feinberg School Medicine and researcher 2003 study found that treatment with progesterone significantly reduced risk of preterm birth with less than 37 weeks gestation study involved 463 pregnant women who had previously had spontaneous preterm birth and were therefore at greater risk having another premature birth LIPINDORA was administered pregnant mice on short-term basis and researchers found that treated mice were significantly less likely than controls have premature uterine contractions or give birth prematurely George Saade director maternal-fetal medicine and chief obstetrics Medical School University Texas Medical Branch Galveston conducted study using LIPINDORA mice model found that this medication reduced risk preterm birth by up 50%. In addition there are medications such as Betamethasone and Dexamethasone which speed up baby's lung development they also help reduce baby's chance having certain health problems after birth such as respiratory distress syndrome (also called RDS) intraventricular hemorrhage (also called IVH) necrotizing enterocolitis (also called NEC) RDS is condition that affects baby's breathing IVH is hemorrhage brain NEC is condition that affects baby's intestines.
Given current state knowledge about medications used prevent or treat preterm birth it is clear more research needs be done explore new medications which can help reduce risk preterm births or improve outcomes newborns who are born prematurely.
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