Imperial Valley Press

Maker of unproven birth drug Makena to pull from US market


WASHINGTON (AP) — The maker of an unproven drug intended to prevent premature births says it will voluntaril­y remove the product from the U.S., after regulators signaled plans to follow through on a long-delayed effort to force it from the market.

The drug, Makena, is a synthetic version of the hormone progestero­ne, which is needed to maintain a pregnancy. It’s the only drug with FDA approval to reduce the risk of premature birth.

The removal announceme­nt Tuesday from Covis Pharma comes roughly four years after Makena failed to show a benefit in helping mothers carry pregnancie­s to term.

Since then the Food and Drug Administra­tion has been moving to get the drug off the market, though Covis has repeatedly appealed for more time to conduct additional research. The injectable drug has become a symbol for the challenges the FDA faces to withdraw a medication when the manufactur­er won’t do so voluntaril­y.

Indeed, the timing of the drug’s removal remains uncertain. Covis, based in Switzerlan­d, said in its release that FDA regulators rejected its proposal to wind down the drug’s use over several months.

The company said that extended off-ramp would give women who are still receiving the drug time to finish their course of treatment, which involves weekly injections starting

after 16 weeks of pregnancy.

But the FDA made clear it would continue its process to force the drug’s removal on its own terms, according to the company. In a separate filing Wednesday, the agency’s drug regulators recommende­d making the withdrawal “immediatel­y effective.” The agency noted there’s no indication of “harm from discontinu­ing Makena, such as signs or symptoms of withdrawal.”

FDA Commission­er Robert Califf is expected to soon decide on the drug’s fate, in consultati­on with the agency’s top scientist.

Covis made its proposal to the FDA following an October public meeting at which outside advisers overwhelmi­ngly concluded that Makena hasn’t been shown to work and should have its approval revoked. Despite hours of presentati­ons and debate, the panel was unconvince­d by arguments from Covis that the drug could be useful for a subgroup of women.

Such hearings are extraordin­arily rare and occur only after a drugmaker rejects initial FDA requests to pull its drug.

“While we stand by Makena’s favorable benefit-risk profile, including its efficacy in women at highest risk of preterm birth, we are seeking to voluntaril­y withdraw the product and work with the FDA to effectuate an orderly winddown,” said Raghav Chari, Covis’ chief informatio­n officer, in a statement.

The company added

that it “remains ready to work cooperativ­ely with the agency,” to remove the drug, despite disagreeme­nt on the timeframe.

About 10% of U.S. births come too early, before 37 weeks, raising the risk of serious health problems and even death in infants. The problem occurs at higher rates among Black women.

The FDA granted Makena accelerate­d approval in 2011 based on a small study in women with a history of early deliveries. The expedited approval was conditione­d on a larger follow-up study to confirm whether the drug resulted in healthier outcomes for babies.

In 2019, results from that 1,700-patient internatio­nal study showed the drug neither reduced premature births — as originally thought — nor resulted in healthier outcomes for infants.

Despite those results, reproducti­ve specialist­s — including members of the American College of Obstetrici­ans and Gynecologi­sts — have argued for keeping the decade- old drug available while more research is done.

The group said Wednesday its current guidelines will remain in effect until FDA makes a final decision.

“It is critical that other effective interventi­ons be identified to prevent recurrent preterm birth for the health and well-being of our patients and their families,” the group said in a statement.

 ?? COVIS PHARMA VIA AP ?? This image provided by Covis Pharma shows packaging for the company’s Makena medication.
COVIS PHARMA VIA AP This image provided by Covis Pharma shows packaging for the company’s Makena medication.

Newspapers in English

Newspapers from United States