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Merck to seek FDA authorization for its new antiviral Covid-19 treatment

Source : 112 Ukraine

Phase III data showed an approximately 50% reduction in the risk of hospitalization or death in patients 29 days after treatment with the pill
12:31, 4 October 2021

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US pharmaceutical company Merck will pursue FDA emergency use authorization (EUA) “as soon as possible” for molnupiravir, the Covid-19 oral antiviral candidate it is developing with Ridgeback Biotherapeutics. It is reported by Voice of America. 

Phase III data showed an approximately 50% reduction in the risk of hospitalization or death in patients 29 days after treatment with the pill.

Merck announced results from an interim analysis of data from 775 patients in the Phase III portion of the MOVe-OUT trial (also called MK-4482-002; NCT04575597), which it said showed that 28 of 385 patients (7.3%) who received molnupiravir were either hospitalized or died through Day 29 following randomization, compared with 53 of 377 patients (14.1%) treated with placebo.

Through Day 29, no deaths were reported in patients who received molnupiravir, compared with eight deaths in patients who received placebo.

Molnupiravir reduced the risk of hospitalization and/or death across all key subgroups, Merck said, adding that efficacy was not affected by timing of symptom onset or underlying risk factor. An analysis of the approximately 40% of patients with available viral sequencing data found molnupiravir to have shown consistent efficacy across the Gamma, Delta, and Mu variants of SARS-CoV-2.

Related: First Ukrainian-made vaccine will be produced next year, - Health Minister

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