RESEARCH – On a sample of 775 patients, the antiviral developed by the Merck laboratory has allowed hospitalizations to be halved. The European Medicines Agency announced on Monday the launch of an accelerated review for authorization in the EU.
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After the more than encouraging results of a drug against Covid unveiled in early October by Merck, the European regulator is taking the plunge. The European Medicines Agency (EMA) announced this Monday, October 25 the launch of the accelerated review of the pill from the American laboratory Merck, an easy-to-administer remedy destined to become a crucial tool in the fight against the pandemic, because it is complementary vaccines.
“The EMA’s Committee for Medicinal Products for Human Use (CHMP) has launched an ongoing review of the oral antiviral drug molnupiravir (…) for the treatment of Covid-19 in adults”, the Amsterdam-based institution said in a statement.
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The Merck laboratory also filed in mid-October an emergency authorization file across the Atlantic with the American Medicines Agency (FDA). And without waiting for American or European approval, Merck already plans to manufacture 10 million treatments by the end of 2021.
Significant decrease in hospitalizations
The development of this pill could constitute a major breakthrough in research on Covid. Concretely, it could become the first effective oral drug against the disease, if the results observed during the clinical phase are confirmed.
The American laboratory Merck has published promising data on the effectiveness of molnupiravir, obtained during the last phase of its clinical trials, phase 3. On a sample of 775 people suffering from a mild to moderate form and with at least one risk factor, the pill halved hospitalizations and reduced deaths to zero. This was ingested by the patients five days after the onset of their first symptoms.
In detail, the hospitalization rate was 7.3% in the group that received the drug and 14.1% in the one that received the placebo. No deaths were noted in the first group, while eight occurred in the second. A priori very effective, molnupiravir could also considerably limit contamination since it is composed of antivirals, which prevent the virus from replicating in the body.
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Last Wednesday, the Bill and Melinda Gates Foundation announced an investment of up to $ 120 million to facilitate poor countries’ access to this pill. The money invested will be used in particular to encourage the production of generics of the drug by companies, in particular in India, to which Merck has already granted a license.
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