Merck's COVID-19 pill isn't quite as effective as initially reported

Pharmaceutical companies Merck and Ridgeback Biotherapeutics have published an update on molnupiravir, a pill formulated to help treat COVID-19 by reducing one's risk of being hospitalized with or dying from the disease. According to the latest details from the company, molnupiravir isn't quite as effective as the interim analysis had previously found.

Merck and Ridgeback published the update on the molnupiravir MOVe-OUT study on Friday, noting that it now has the data from all of the participants who were enrolled in the study. Based on that data, the companies say their oral antivirus medication offers a relative risk reduction of 30-percent in COVID-19 patients, a decrease from the previously stated 48-percent.

Likewise, the update reveals molnupiravir cut the risk of hospitalization and death among COVID-19 participants to 6.8-percent compared to 9.7-percent in the placebo group. These figures are compared to the 7.3-percent and 14.1-percent reported with the interim analysis.

The update is disappointing news that arrives just ahead of a planned FDA advisory committee review of the drug, its effectiveness, and its safety profile. Assuming the committee endorses the drug, it'll then be up to the FDA to decide whether to grant an Emergency Use Authorization (EUA) for the oral antiviral treatment.

The FDA's advisory panel will meet tomorrow, November 30, to determine whether they'll give their recommendation for a EUA. As with the COVID-19 vaccines, booster shots, and other products granted emergency authorization throughout the pandemic, the experts will look into whether any known risks associated with the drug would outweigh any potential benefits, the product's safety, and how effective it is at reducing severe COVID-19 outcomes.

The pharmaceutical companies had submitted a request with the FDA for emergency authorization in October. Molnupiravir is intended for adults who have mild or moderate COVID-19 and who are determined to be at high risk of severe outcomes. The treatment, should it receive an emergency authorization, would be the first oral treatment option for COVID-19, joining monoclonal antibodies, which are also used in high-risk patients.

Despite the revised effectiveness, experts still anticipate the FDA will ultimately authorize Merck's drug as another tool for treating COVID-19 cases (via NBC). The bigger question is who would be covered by the EUA, assuming one is granted. The drug is intended for those who are at high risk of hospitalization and death from COVID-19, but it is possible an authorization may further limit who is able to receive the oral antiviral treatment, depending on the safety data.