Anti covid pills, Ema: “Let’s hope ok at the beginning of 2022”

On antiviral anti-covid pills, EMA is “moving forward rapidly with the authorization process” under consideration for the treatment of coronavirus. “And we really hope that early next year we will be able to finish for both.” This was explained by Marco Cavaleri, head of Vaccines and Therapeutic Products for Covid-19 of the European Medicines Agency Ema, speaking during the last update of 2021 dedicated to the press of the two oral antivirals against Covid, that of Merck (Msd outside from the USA and Canada) and that of Pfizer. The expert recalled that for the Merck pill “the final results recently made available from the main clinical trial showed a reduced efficacy” compared to that previously communicated. “These data will be reviewed in the coming weeks – he concluded – to determine if a positive opinion can be reached” on the green light to the drug “next year”. PILL COMING IN ITALY – The two anti-covid pills, molnupiravir (Merck) and paxlovid (Pfizer), “will be available in Italy starting from the end of January 2022”. This was stated by the director general of Aifa, Nicola Magrini, in a videoconference hearing in the Hygiene and Healthcare Commission of the Senate. “Molnupivarir, for which there was a subsequent communication in the final study of a 30% reduction in the initially claimed effect, had a positive preliminary evaluation and was given for a procurement of the drug, but the dossier was approved. it will take place on the analysis of the update “, Magrini specified. On the Pfizer pill – he recalled – it has “an efficacy of 89% in reducing hospitalizations”: the evaluation “of the final study is in progress, but we are moving towards procurement”. MERCK PILL – Merck’s anti covid pill will need to be taken 2 times a day for 5 days to cure the disease. Therapy must begin within 5 days of the first symptoms, according to the indications of the European drug agency Ema on the antiviral pill molnupiravir for the treatment of Covid-19, developed by Merck Sharp & Dohme (Merck in USA and Canada) in collaboration with Ridgeback Biotherapeutics. According to updated data from the Move-Out study, the pill reduces the relative risk of hospitalization or death from Covid by 30%. An efficacy that is lower than that previously reported in the interim analysis of the same trial, which reported a halving of the risk (48% reduction) Therapy, according to the advice issued by the Committee for Medicinal Products human Chmp of the Ema, should begin “as soon as possible” after diagnosis, and “within 5 days of the onset of symptoms”. The drug, which is available in capsules, will need to be taken “2 times a day for 5 days”. Its use “is not recommended in pregnancy”. And breastfeeding “must be stopped during treatment and for 4 days after treatment”. The drug, which is not currently authorized in the EU, can be used to treat adults with Covid who do not require supplemental oxygen and who are at increased risk of developing severe disease. The drug is also not recommended in women who may become pregnant and are not using effective contraception. Women who could become pregnant must use effective contraception during treatment and for 4 days after the last dose of Lagevrio, says Ema. PFIZER PILL – At the end of November, the EMA announced the start of a review on Pfizer’s anti-covid pill. “The EMA – explained the EU regulatory body – is examining the data currently available” on the pill which should represent a step forward on the home care front, “and is launching this review to support national authorities who could decide on its use. early, for example in emergency settings, before marketing authorization “. The CHMP Committee for Medicinal Products for Human Use reviews data from a study comparing the effect of Paxlovid versus placebo in patients with Covid from mild to moderate, not hospitalized, but at risk of progression to severe disease. Preliminary results indicate that the treatment reduced the risk of hospitalization or death compared to placebo when administered within 3 to 5 days of onset of symptoms. The CHMP will also examine data on the quality and safety of the drug. “Although a more comprehensive rolling review is expected to begin before a possible application for marketing authorization – the agency said – this review will provide recommendations. at EU level as soon as possible, so that they can be used by national authorities wishing to make evidence-based decisions on early use of the medicine “.