Reply to the FDA’s “Decision rejection” on a cancer drug that’s supposed to prevent births and improve neonatal outcomes”

The FDA pulled its approval for a drug that was supposed to prevent premature births, but that it wasn’t effective.

Covis said it outlined a withdrawal plan after the committee hearing, with a wind-down period for patients to finish their treatment. However, the FDA’s Center for Drug Evaluation and Research rejected the plan.

FDA Commissioner Robert M.Califf said in a statement on Thursday that the scientific research and medical communities have not yet found a treatment that is effective in preventing preterm birth and improving neonatal outcomes.

Hundreds of thousands of babies are born preterm every year in the U.S. It’s one of the leading causes of infant deaths, according to a report released by the March of Dimes last year. Black infants are more likely to have premature births compared to other groups. There is no other approved treatment for preventing preterm birth.

Califf and their chief scientist, however, quoted an advisor of the agency, Dr. Anjali Kaimal, who is a professor at the University of South Florida.

Kaimal said there should be another trial to test the drug’s efficacy, but in the meantime, it doesn’t make sense to give patients a medicine that doesn’t appear to work: “Faced with that powerless feeling, is false hope really any hope at all?”