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FDA forces to remove pregnancy drug, company pushes back

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WASHINGTON (AP) — The maker of the only US drug aimed at preventing preterm birth is making a final effort this week to keep its drug on the market, despite health regulators insisting it’s not working.

The Food and Drug Administration meeting, which began Monday, comes more than two years after the agency declared the drug ineffective and called for its removal. Pharmaceutical manufacturer Covis Pharma has challenged the agency’s conclusion by arranging a highly unusual three-day public hearing.

The meeting highlights the limits of the FDA’s mandate and, in rare cases, the long, painstaking process to remove a drug when a company does not voluntarily do so at the agency’s request.

The trial will resemble a court hearing, with FDA staff and company scientists presenting arguments for and against the drug Makena, then voted on Wednesday by a panel of outside experts. FDA leaders will make the final decision on whether to order a withdrawal.

About 10% of births in the US are very premature – before 37 weeks, it increases the risk of serious health problems and even death in infants. Complicating the Makena debate is the leading US obstetrics group’s support for ten years of keeping the drug available while more research is done.

“The need for effective treatment for preterm labor is great,” says the American College of Obstetricians and Gynecologists. “Makena and associated generics represent the only treatment currently available to obstetrician-gynecologists to help prevent this condition.”

But the FDA says current data shows that weekly injections of the drug do not help prevent premature birth again.

The FDA’s chief of drugs, Dr. “Based on the evidence shown today, Makena is not shown to be effective,” Patrizia Cavazzoni said in her keynote speech on Monday. “The benefit and risk profile is unfavorable and should be withdrawn from the market.”

The dispute is likely to increase scrutiny of the agency’s so-called accelerated approval program.While this allows for drugs like Makena to be brought to market based on promising early results, larger additional studies are often done.

Washington University of St. “Makena is used as an example of many different criticisms of this program,” said Rachel Sachs, expert in food and drug law at St. “This may not be fair for other drugs, other diseases, other patient groups, but we have to respond to the situation it presents.”

At its best, its accelerated approval program is credited with accelerating the availability of breakthrough treatments for HIV and cancer. But in the last decade, the FDA has been increasingly criticized for failing to track accelerated drugs with incomplete or unconvincing confirmatory data, including the many expensive cancer drugs on the market.

In recent years, the FDA’s cancer division has begun to encourage companies not to sell their drugs for uses granted under these so-called “dangerous approvals.”

The FDA approved Makena in 2011 based on a small study that suggested it reduces preterm birth rates in women with a history of preterm birth. Makena consists of a synthetic version of the hormone progesterone, which helps the uterus grow and maintain a pregnancy. Women can start shots after 16 weeks of pregnancy.

The expedited approval was granted on the condition that Makena’s original developer, Hologic, conduct a follow-up study confirming that the drug resulted in lower rates of disability and death among newborns.

But the results of an international study of 1,700 women released in 2019 showed that the drug neither reduced preterm births – as originally thought – nor increased the risk of blood clots, depression and other side effects in mothers while having healthier outcomes for babies.

In briefing documents released this month, the FDA said leaving Makena on the market “leads to false hopes, treatment-related risks and other burdens, such as excessive medical expenses.” According to a recent federal reportThe US has spent $700 million on Makena since 2018 through various government programs such as Medicaid and Veterans Affairs.

The FDA opinion also applies to several generic versions of the shot.

Drug maker Covis argues that Makena is effective, and the flaws in the 2019 study hide its usefulness. The Luxembourg-based company cites black women as being at higher risk for preterm birth, but only 7% of women in the international study, compared to 59% in the original US study used for confirmation. It takes time to conduct another study in high-risk patients, particularly Black Americans.

A patient group funded by Covis, the Alliance for Preterm Birth Prevention, put forward similar arguments in their letter to the FDA.

“We believe there is no sound public health reason to deny patients and doctors access to Makena,” the company said in an emailed statement.


Follow Matthew Perrone on Twitter: @AP_FDAwriter


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