Plyushkin
Merck (NYSE:MRK) and Ridgeback Biotherapeutics’ COVID Lagevrio tablet (molnupiravir) failed to achieve the number one goal of showing the benefits of reducing hospitalizations and deaths in older adults in a real-world study called PANORAMIC in the United Kingdom.
On October 6, the companies reported knowledge of 3 studies: PANORAMIC, Clalit and one of carcinogenicity in transgenic mice.
PANORAMIC:
The study, which included 25,783 people, was conducted through the University of Oxford in the United Kingdom on highly vaccinated adults, most commonly younger than 65, at a time when the circulating variant was primarily Omicron.
In the test, another 12,821 people gained Lagevrio plus the same previous care, while 12,821 gained only the same previous care. Data on the number one results was available for 25,000 Americans (97%).
The companies reported that the number one goal of reducing hospitalizations and deaths within 28 days of randomization, compared to the same previous care, was not met because 0. 8% of patients in the Lagevrio organization (n=103/12,516) and the same previous care organization (n=96/12,484) were hospitalized or died.
For the number one secondary endpoint of time to first self-reported recovery, it was 6 days shorter for those in the Lagevrio organization (9 days) compared to the same previous care organization (15 days).
The corporations added that after adjusting for age and baseline comorbidity, there was an estimated 4-day improvement in recovery time in the Lagevrio organization (10. 4 days) compared to the same previous care organization (14. 5 days).
Clalit Studio:
In this observational and retrospective cohort study, conducted by researchers in Israel, Lagevrio showed a decrease in the rate of hospitalizations and mortality from COVID-19 in patients 65 years and older, but in young adults, corporations ed.
In patients ≥65 years of age (n=13,569), COVID hospitalizations, the number one endpoint, occurred in 18 patients treated with Lagevrio (7four,6 consistent with 100,000 consistent with days) and 513 untreated patients (127. 6 consistent with 100,000 consistent conson-days). ). The secondary endpoint of COVID-19 deaths in the same age organization occurred in four of 845 patients treated with Lagevrio and 137 of 12,72four untreated patients, according to the companies.
In patients older than 40 to 6 years (n=6229), COVID-19-related hospitalizations, the number one goal, occurred in 8 treated patients (125. 8 consistent with 100,000 consistent with days) and 97 untreated patients (four9. 1 consistent with 100,000 consistent with the same days). Meanwhile, the secondary endpoint of COVID-19 deaths in the same age organization occurred in four of 22 four patients treated with Lagevrio and 7 of 6,075 untreated patients, Merck added.
Study of mice:
Merck states that data from a study (Tg RasH2) comparing carcinogenicity in transgenic mice given molnupiravir orally for six months at doses of 30, 100 or 300 mg/kg/day showed that LAGEVRIO is not carcinogenic.