Den Haag: EU drug watchdog on Friday supports Merck’s anti-covid pills for emergency use ahead of its formal authorization and began reviewing Pfizer antivirus care as a soaring case throughout Europe.
Two pills by Giant Pharma As represent a potentially breakthrough step in the fight against Coronavirus as research shows that they cut the risk of hospitalization and death in high-risk patients.
The European Medicine Agency (EMA) said that while Merck pills had not been approved, it had “issued suggestions” so that the individual countries in 27 EU countries could decide whether to use it if there was a surge in infection.
“Medicine, which is currently not authorized in the EU, can be used to treat adults with Covid-19 which does not require additional oxygen and at a higher risk of developing Covid-19,” EMA said in a statement.
“EMA issued this suggestion to support national authorities that might decide the possibility of use of medicine before marketing authorization, for example in setting up emergency use, given the increase in infection and death due to Covid-19 in all EU.” Merck pills may not be used by pregnant women or women who do not use contraception and can get pregnant, Ema said.
“This recommendation is given because laboratory studies in animals have shown that high doses (Merck pills) can have an impact on the growth and development of the fetus,” he added.
Amsterdam-based watchdog said hoping to decide on formal approval for Merck pills, also known as Molnupiravir, at the end of the year.
Separately EMA says it has started a review of Pfizer pills so that it can provide the same advice.
“Ema is reviewing the current data on the use of Paxlovid, oral treatment for Covid-19 developed by Pfizer,” said EMA.
The complete “review” review for formal approval is expected to begin next week, but EMA says you want to help national authorities “in the short term as possible”