Merck & Co said on Friday updated data from its study on its experimental COVID-19 pill showed the drug was less effective in cutting hospitalizations and deaths than previously reported.
The drugmaker said its pill showed a 30% reduction in hospitalizations and deaths, based on data from over 1,400 patients. In October, its data showed a roughly 50% efficacy, based on data from 775 patients. ...
The company filed for a U.S. authorization of the drug molnupiravir on Oct. 11, following the interim data.
Merck said on Friday the data on molnupiravir, developed with Ridgeback Biotherapeutics, had been submitted to the U.S. Food and Drug Administration ahead of a meeting of its expert advisers on Tuesday.
The FDA's scientists are expected to publish their briefing documents ahead of the meeting as early as Friday.
The panel is expected to vote whether to recommend that the agency authorize the oral capsules for the treatment of mild-to-moderate COVID-19 in adults who are at risk of severe disease.
A planned interim analysis of the data last month showed that 7.3% of those given molnupiravir twice a day for five days were hospitalized and none had died by 29 days after the treatment. That compared with a hospitalization rate of 14.1% for patients on placebo.
In the updated data, 6.8% of those given molnupiravir were hospitalized and one person died, while the other placebo group had a hospitalization rate of 9.7%.
