LAGEVRI did not demonstrate statistically significant reduction in COVID risk following household exposure to another individual with COVID: Merck
Rahway: Merck, known as MSD outside the United States and Canada, has announced that LAGEVRI (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.”
LAGEVRIO is approved or authorized in several markets including the U.S., United Kingdom, Australia, China and Japan, for the treatment of certain adults who have been diagnosed with COVID-19. LAGEVRIO is not authorized for pre-exposure or post-exposure prophylaxis for prevention of COVID-19.
LAGEVRIO (molnupiravir) (MK-4482) is an investigational, orally administered nucleoside analog that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19.
Merck and Ridgeback’s “orange COVID-19 pill” is a Swedish Orange opaque capsule with the Merck corporate logo and “82” printed in white ink, available in certain markets as LAGEVRIO.
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