A preliminary analysis of the University of Oxford’s open label, prospective real-world evidence study, PANORAMIC, conducted in the UK in highly-vaccinated adults mostly <65 years of age, showed no evidence of a difference between LAGEVRIO added to usual care compared to usual care alone for the reduction of hospitalizations and deaths through Day 28 (primary endpoint was not met); the incidence of hospitalizations and death through Day 28 was very low overall (0.8% in both groups).
The main secondary endpoint (time to first self-reported recovery) in the PANORAMIC study was 6 days shorter with the LAGEVRIO group compared to the usual care group; in addition, the use of LAGEVRIO also was associated with earlier recovery across a wide range of other symptom measures, as compared to the usual care group.
An analysis of real-world data from a separate observational, retrospective study conducted by investigators in Israel (known as the Clalit study) showed that in a cohort of non-hospitalized, high-risk patients, LAGEVRIO reduced hospitalizations and mortality due to COVID-19 in patients 65 years and above; no evidence of benefit was found in younger adults ages 40 to 64 years.
Results from a separate, non-clinical 6-month carcinogenicity study in mice demonstrated that LAGEVRIO was not carcinogenic.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.