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Nov. 19 (Reuters) – The European Union’s medicines regulator has issued advice on using Merck’s COVID-19 pill (MRK.N) for adults and has started reviewing a rival tablet from Pfizer ( PFE.N) to help Member States decide on adoption quickly before any formal EU-wide approval.
In two separate statements on Friday, the European Medicines Agency (EMA) detailed efforts to advance the use of experimental but promising options, as COVID-related infections and deaths are increasing rapidly in the region and forcing to new blockages. Read more
EMA noted Merck’s COVID-19 tablet, Lagevrio, developed with Ridgeback Biotherapeutics, should be administered early and within five days of first symptoms to treat adults who do not need oxygen and are at risk of worsening their disease.
He advised against treatment during pregnancy and for women who are planning or could become pregnant, adding that breastfeeding should also be stopped when using the pill, which should be taken twice a day for five days.
Drugs in the same class as Merck’s Lagevrio have been linked to birth defects in animal studies. The drug maker, known as MSD outside of the United States and Canada, said animal testing showed its pill to be safe, but the data has not been made public.
EMA noted He was reviewing available data on the Pfizer Paxlovid pill, days after the drugmaker sought US approval, adding that a more comprehensive ongoing review had to begin before any approval was granted. He did not specify when this review would take place.
The EMA began an ongoing review of the Merck pill last month and hopes to complete that review by the end of the year.
Pfizer this week requested emergency use of its tablet in the United States following data showing the pill reduced the risk of hospitalization or death by 89% in adults who were at risk of their disease. get worse. Read more
Merck’s pill, which was approved by Britain earlier this month, has been found to halve those chances when given early in the disease.
While vaccines are at the heart of the fight against the pandemic, regulators are studying therapies, including the Pfizer and Merck pills, and the EMA last week backed the drugs from Regeneron-Roche (REGN.O), (ROG .S) and Celltrion (091990. KQ).
Unlike regulators in the United States, the world’s largest pharmaceutical market, the European Union’s EMA does not have emergency use procedures for treatments or vaccines, and often relies on a process longer authorization.
But in the face of increasing COVID-19 cases, the EMA has offered its scientific expertise to countries that may need advice on early use before any broader recommendations from the regulator.
While reviews of COVID-19 pills are underway, the EU is also negotiating with Merck and Pfizer over possible contracts to supply their tablets, an official told Reuters last week, adding that talks with Merck were over. advances.
Report by Pushkala Aripaka in Bangalore; Editing by Arun Koyyur, Giles Elgood and Barbara Lewis
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