After the first data that had aroused enthusiasm about the decrease of up to 50% of hospitalizations and deaths in non-serious patients “there was a cold shower and that percentage had dropped to 30%. Today the European Medicines Agency – which on 25 October had started the review of the data on the Merck antiviral pill – begins to examine the new data from the main study on the antiviral pill molnupiravir (Lagevrio *), which show a reduced efficacy. of the drug for the treatment of Covid-19, in terms of reducing the risk of hospitalization or death.
For the oral antiviral developed by Merck Sharp & Dohme in collaboration with Ridgeback Biotherapeutics, the EU regulatory body had issued provisional recommendations in November to support national authorities in any decisions on early use of the product, prior to authorization for the product. placing on the market (Aic). These recommendations – recalls the EMA – were based on an evaluation of the provisional data of the study, then available on 762 people, which showed halved the risk of hospitalization or death in those at risk (from 14.1% in the placebo group to 7.3% in the antiviral group).
The study did not include people who had been vaccinated. Now the updated results, based on 1,408 trial participants, show that Lagevrio reduced the risk of hospitalization or death in people with Covid-19 at higher risk of serious illness from 9.7% in the placebo group to 6.8% in the group of treaties, therefore to a lesser extent than the results previously emerged. “The previous recommendations remain unchanged“, The EMA points out in a note in which it explains that it will“ evaluate ”these additional data“ as part of a more complete marketing authorization application ”. The entity “will further communicate the outcome of the application currently under review”. There is a lot of anticipation on these oral antivirals, especially in these days when the epidemic data is on the rise. The drug from Merck (MSD outside the US and Canada) and Ridgeback Biotherapeutics works by reducing the ability of the virus to replicate in the body. It does this by increasing the number of mutations in the genetic material of the virus (Rna).
Meanwhile thePfizer pharmaceutical company reported that clinical studies have confirmed the effectiveness of its antiviral pill against Covid-19, which has reduced hospitalizations and deaths among people at risk by almost 90% when it was taken in the first few days after symptoms appeared. The results – already announced in early November – are based on tests conducted on over 2,200 people and confirm the results announced last month by preliminary studies. The company also said the treatment looks like be effective against the Omicron variant. For Pfizer CEO Albert Bourla, the new drug (Paxlovid) could “save lives”. The study, says the pharmaceutical company, showed that the pill reduced the need for hospitalization in high-risk adults with Covid-19 by 89% if the treatment was given within three days of the onset of symptoms and the disease. 88% when given within 5 days. And the lab data, Pfizer says, also shows that the pill also appears to be effective in treating people infected with the Omicron variant. “We are confident that, if authorized or approved, this potential treatment could be a vital tool in helping stop the pandemic,” Bourla said.
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