EU regulator grants emergency nod to Merck's anti-Covid pill

TheEU's drug watchdog on Friday backed Merck's anti-Covidpillfor emergency use ahead of its formal authorisation and started reviewing Pfizer's antiviral treatment as cases soar across Europe.

The two pills by the US pharma giants represent a potentially groundbreaking step in the fight against coronavirus as studies show they cut the risk of hospitalisation and death in high-risk patients.

The European Medicines Agency (EMA) said that while the Merckpillwas not yet approved, it had "issued advice" so that individual countries in the 27-nationEUcould decide whether to use it in case of a surge in infections.

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"The medicine, which is currently not authorised in theEU, can be used to treat adults withCOVID-19 who do not require supplemental oxygen and who are at increased risk of developing severeCOVID-19," the EMA said in a statement.

"EMA issued this advice to support national authorities who may decide on possible early use of the medicine prior tomarketing authorisation, for example in emergency use settings, in light of rising rates of infection and deaths due toCovid-19 across theEU."

The Merckpillshould not be used by pregnant women or women who are not using contraception and could get pregnant, the EMA said.

"These recommendations are given as laboratory studies in animals have shown that high doses of (the Merckpill) can impact the growth and development of the foetus," it added.

Thepillshould be given as soon as possible afterCovidsymptoms start, at the latest within five days. It should then be taken for five days, the EMA said.

The Amsterdam-based watchdog says it hopes to decide on formal approval for the Merckpill, also known as molnupiravir, by the end of the year.

'Shortest possible timeframe'

Separatelythe EMA said it had started a review of Pfizer'spillso that it could give similar advice.

"EMA is reviewing currently available data on the use of Paxlovid, an oral treatment forCOVID-19 developed by Pfizer," the EMA said.

A full "rolling review" for formal approval is expected to start next week, but the EMA said it wanted to be able to help national authorities "in the shortest possible timeframe".

Trials show both pills are particularly effective in treating newly-infected high-risk patients when given within days of the onset of the disease.

They are both cheaper and easier to administer than other antivirals which need to be taken intravenously, and also cheaper than vaccines to make, with a simpler supply chain.

Merck'spilldecreases the ability of the coronavirus to multiply by increasing the number of mutations in its genetic material (or RNA).

The Pfizerpilluses a different method, belonging to a class of antivirals called "protease inhibitors", which block the action of an enzyme that is critical to viral replication.

It is a combination of a new molecule, PF-07321332, and HIV antiviral ritonavir.

Europe has been searching for whatever methods it can to curb a fourth wave ofCovidcases that has already prompted several countries to tighten restrictions.

The EMA warned on Thursday that countries should "close the gap" on vaccinations as many of those in hospitals were unvaccinated.