EMA approved anti-covid drug from MSD – SME.sk

AMSTERDAM. The European Medicines Agency approved an emergency antiviral for covid from MSD-Merck Sharp & Dohme on Friday for emergency use.

She also announced that she had started researching a similar drug from Pfizer, AFP reported.

“The medicine (from MSD-Merck Sharp & Dohme), which is not currently approved in the EU, can be used to treat adult patients with COVID-19“who do not need supplemental oxygen and who are at increased risk of severe covide,” the EMA said in a statement.

It should be applied as soon as possible

Lagevrio, available as orally administered capsules, also known as molnupiravir or MK4482, has been approved for emergency use.

According to the EMA recommendation, it should be applied as soon as possible after the diagnosis of covid and within five days of the onset of symptoms. It should be taken twice a day for five days.

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The EMA’s recommendation is based on an analysis of available data on drug quality and the results of completed or ongoing clinical trials, according to a statement published on the Amsterdam-based medicines agency’s website.

Only mild to moderate side effects such as diarrhea, nausea, dizziness and headache have been reported. It is not recommended for use in pregnant women.

Based on Friday’s EMA recommendation, individual EU member states can issue their own guidelines for using Lagevria. A more detailed and comprehensive process, which may result in standard drug approval for the EU market, will continue.

They are also considering a medicine from Pfizer

In addition, EMA announced that it had begun evaluating available data from another Pfizer oral antiviral drug, Paxlovid (PF-07321332 / ritonavir), which reduces virus replication in the human body and may significantly reduce the risk of hospitalization and patient deaths, according to preliminary clinical trials. s covidom.

As with MSD, this review could result in consent to the emergency use of Paxlovid in individual Member States, even before its official full approval for the EU market.

The ongoing evaluation process will be fully operational from next week. The EMA emphasized that it wanted to reach out to those states that were interested in using the anti-virus from Pfizer, “in the shortest possible time”.