Merck Releases Updated Data on its COVID-19 Antiviral
Merck now says molnupiravir reduces the risk of hospitalization or death from COVID-19 by 30% after all data have been analyzed. Previously, an interim analysis showed a 50% reduction in hospitalization or death.
An analysis of all enrolled patients in the study of molnupiravir showed that the antiviral to treat COVID-19 reduced the risk of hospitalization or death from 9.7% in the placebo group to 6.8% in the molnupiravir group, for a relative risk reduction of 30%. Nine deaths were reported in the placebo group, and one in the molnupiravir group in the phase 3 MOVe-OUT clinical trial, which enrolled 1,433 participants. The adverse event profile for molnupiravir remained consistent with the profile reported at the planned interim analysis.
In October 2021, however, developers Merck and Ridgeback Biotherapeutics provided an interim analysis of 762 patients. Researchers found that 7.3% of patients who received molnupiravir were either hospitalized or died through day 29 following randomization, compared with 14.1% of placebo-treated patients. Through day 29, no deaths were reported in patients who received molnupiravir, compared with eight deaths in patients who received the placebo.
Related: Data Show Merck’s Oral Antiviral Cuts Risk of Death from COVID-19 in Half
Merck officials said in a statement that based on the study design, the definitive evaluation of efficacy was considered complete at the planned interim analysis, when the statistical criterion for success was met and enrollment in the study was discontinued at the recommendation of the external Data Monitoring Committee and the FDA.
Merck has shared these additional analyses with the FDA, and the data will be presented to the FDA’s Antimicrobial Drugs Advisory Committee on Nov. 30, 2021.
Molnupiravir has been authorized for use in the U.K. The FDA is reviewing Merck’s application for emergency use authorization. The European Medicines Agency is reviewing Merck’s application for marketing authorization.
Molnupiravir was invented at Emory University and licensed to Ridgeback Biotherapeutics by Drug Innovation Ventures at Emory. It is being develop by Merck in collaboration with Ridgeback.
Navitus to Offer Unbranded Stelara Biosimilar, Remove Stelara from Formulary
March 13th 2025Lumicera Health Services, Navitus’ specialty pharmacy, has made a deal with Teva to offer an unbranded biosimilar that they estimate will save $112,000 and $336,000 per patient per year. Navitus will remove Stelara from formulary on July 1, 2025.
Read More
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
Listen
FDA Approves Neffy 1 mg Nasal Spray for Pediatric Patients
March 6th 2025Neffy 1 mg is now approved by the FDA to treat pediatric patients who weigh 33 to 65 lbs. Neffy was first FDA-approved as a 2 mg dose in August 2024 for the emergency treatment of anaphylaxis in children and adults weighing at least 66 lbs.
Read More
