The FDA says Merck’s COVID-19 pills are effective; Experts will conduct a safety review
Federal health regulators say Merck’s experimental COVID-19 pill is effective against the virus, but they will seek input from outside experts about the risks of birth defects and other potential problems during pregnancy.
The FDA published its analysis of the pills ahead of a public meeting next week where academics and other experts will assess their safety and efficacy. The agency is not required to follow the advice of the group.
The FDA scientists said their review identified several potential risks, including potential toxicity and birth defects. Given these risks, the FDA will ask its advisors whether the drug should never be given during pregnancy or if it can be made available in certain situations.
Under this scenario, the FDA said the drug would carry warnings about risks during pregnancy, but doctors would still have the option to prescribe it in certain cases where its benefits could outweigh its risks for patients.
Given the safety concerns, the Food and Drug Administration said Merck has agreed not to use the drug in children.
In addition, the US Food and Drug Administration noted concerns that Merck’s drug led to subtle changes in the spike protein characteristic of the coronavirus, which it uses to penetrate human cells. In theory, the FDA has warned that these changes could lead to dangerous new variants.
Regulators also note that Merck has collected far less safety data overall on its drug than it has for other COVID-19 treatments.
The FDA will ask its independent advisors to discuss all of these issues and then vote on whether the drug’s overall benefits outweigh its risks.
All COVID-19 medications currently authorized by the Food and Drug Administration require an injection or intravenous injection and can only be given by health professionals. If licensed, Merck’s drug would be the first drug American patients can take at home to relieve symptoms and speed recovery. Already licensed for emergency use in the UK
The meeting marks the first time organizers have publicly reviewed a new drug for COVID-19, reflecting intense interest and scrutiny for a pill that could soon be used by millions of Americans.
The drug molnupiravir has been shown to significantly reduce hospitalizations and deaths among people with mild to moderate MERS infection.
Merck’s drug uses a new approach to fight COVID-19: It inserts mutations so small in the genetic code of the coronavirus that it cannot reproduce itself.
But this genetic effect has raised concerns that in rare cases the drug can cause birth defects or tumours.
Pregnant women were excluded from the Merck study. Both women and men in the study were instructed to use contraception or to abstain from sex.
Merck, for its part, says the results of two of the company’s studies in rodents show that “molnopiravir does not cause mutagenicity or DNA damage in these animal models.” The company said that rodents received higher doses for longer periods of time than humans who would take the drug.
The FDA reviewers also confirmed previously reported interim findings from Merck that the contraceptive pill reduced hospitalization and death by about half among patients with early symptoms of COVID-19 who had an increased risk of health problems.
However, Merck Friday morning announced updated results from the same study that showed less benefit from the drug.
Among the more than 1,400 adults in the company’s study, molnopiravir reduced the risk of hospitalization and death by 30%, lower than the 50% initially reported based on incomplete results.
Nearly 7% of patients who received Merck within five days of developing symptoms of COVID-19 ended up in the hospital and one died. That compares with the 10% of hospitalized patients who took the placebo and nine deaths.
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