Restricting use of the drug to people who are not pregnant would be a significant population at risk do not have access to a treatment that could probably be prescribed for home use. Pregnant people with Covid can still receive monoclonal antibody treatments, but they must be administered in a healthcare facility.
The FDA will ask advisors to consider an alternative approach, where use of the drug would not be recommended for pregnant people, but health care providers could prescribe it in certain scenarios where the benefits are expected to outweigh the risks. The agency will also urge consultants to discuss whether concerns about the drug’s use in pregnant people extend to individuals who may become pregnant in the future.
The agency will also seek advice on an observed increase in the rate of coronavirus spike protein mutations in molnupiravir patients, including what risk or monitoring strategies should be considered.
Background: Merck announced it sought emergency FDA approval to use its drug on Oct. 11, days after it reported that the antiviral pill appeared to halve the risk of hospitalization or death from Covid in people at risk of developing Covid. a serious illness. The prospect of a pill Covid patients could take to avert the worst effects of disease could help turn the tide of the pandemic by easing pressure on health care systems, many of which are already overwhelmed on their way to the holiday season.
But the availability of antivirals will not be a panacea. The Merck drug and another developed by Pfizer – with an even higher efficacy rate – seem to give the best results when taken shortly after symptoms appear, meaning patients must be diagnosed quickly and given a prescription to the best chance of avoiding serious outcomes.
Participants in the Merck study had one or more of several conditions that were considered risk factors for serious disease, including diabetes, obesity, chronic kidney disease, severe heart disease, chronic obstructive pulmonary disease, cancer, or being older than 60.
Pills are easier to manufacture and distribute than therapies such as monoclonal antibodies, which are administered in healthcare. But the three vaccines available in the US remain the most effective interventions to prevent severe illness, hospitalization and death from Covid.
What’s next: The FDA’s outside antimicrobial drug advisers will meet Tuesday to decide whether the agency will give the green light to the use of the Merck Pill. A similar meeting for Pfizer’s antiviral pill has yet to be scheduled.