By: IPP Bureau
Last updated : February 22, 2023 11:20 am
The safety profile of LAGEVRIO in this trial was generally consistent with that observed in previously reported clinical studies
Merck announced that LAGEVRIO (molnupiravir) did not demonstrate a statistically significant reduction in the risk of COVID-19 following household exposure to another individual with COVID-19.
The Phase 3 MOVe-AHEAD trial evaluated people who did not have COVID-19 at baseline (confirmed by a negative baseline SARS-CoV-2 test and no signs and symptoms) but lived with someone who was recently diagnosed with COVID-19.
In the primary endpoint of participants who did not have evidence of SARS-CoV-2 infection at baseline (confirmed by a negative SARS-CoV-2 test), the LAGEVRIO treated group was observed to be 23.6% less likely than those who received placebo to develop COVID-19 through Day 14 (a positive post-baseline SARS-CoV-2 test with evidence of signs and symptoms); the primary endpoint was not met.
The safety profile of LAGEVRIO in this trial was generally consistent with that observed in previously reported clinical studies and post-authorization experience in the treatment of COVID-19. Merck intends to submit full results from this study for presentation at a scientific meeting or for publication.
“Results from this post-exposure prevention study are scientifically interesting as we continue to learn more about COVID-19. We are grateful to the MOVe-AHEAD trial participants and investigators for their contributions to this study,” said Dr. Dean Y. Li, president, Merck Research Laboratories.
“This was not a treatment study and these results do not impact the efficacy and safety data observed in our Phase 3 MOVe-OUT trial for the treatment of mild-to-moderate COVID-19. We remain focused on our ongoing efforts to bring LAGEVRIO as treatment to appropriate high-risk patients with COVID-19 where its use is authorized or approved, as well as to further study the ways it may benefit patients with other infectious diseases, such as RSV.”