The European Medicines Agency (EMA) announced on November 19 that European countries can use Merck’s coronavirus pills in emergencies caused by an increase in the number of cases, and before its official approval in the European Union.
The European Medicines Agency has issued guidelines for the use of these tablets (which will be marketed under the Lagevrio brand name), while announcing Pfizer began evaluating tablets.
According to these instructions, Merck tablets should be taken twice a day for five days. The drug can be used to treat adult patients with COVID-19 who do not require oxygen support and are at increased risk of developing serious illness.
The pill is not recommended during pregnancy, and for women who may become pregnant and are not using effective contraception. The latter must use effective contraception during treatment and for four days after taking the last dose of the pill.
The EMA also stated that breastfeeding should be discontinued during treatment with these pills and for four days after taking the latter.
Korper said the guidelines could be used to support pre-licensing directives for commercial use. The EMA recommends prescribing Lagevrio as soon as possible after a diagnosis of COVID-19 and within five days of symptom onset.
In terms of safety, the most common side effects reported during treatment and within 14 days after the last dose of Lagevrio were diarrhea, nausea, dizziness, and headache, all of which were mild to moderate. The issued guidelines are based on a review of data, including on the quality of medicines, and the results of extensive and ongoing research.
Lagevrio, when given at 800 mg twice daily, reduced the risk of hospitalization and death when treatment was started within 5 days of symptom onset. About a month after the start of treatment, 14.1% (53 of 377) of patients receiving placebo (placebo) were hospitalized, of which 8 people died. 7.3% of patients (28 of 385) treated with Lagevrio were hospitalized. But none of the patients in the Lagevrio group died.