The EMA has started the review of Paxlovid, Pfizer’s pill, for the treatment of Covid patients. The European Medicines Agency – a note reads – launches this review to support the national authorities could decide on its early use for Covid-19, for example in emergency contexts, before marketing authorization “.
EMA’s Committee for Medicinal Products for Human Use (CHMP) will review data from a study comparing the effect of Paxlovid with that of a dummy treatment (placebo) in non-hospitalized patients with mild to moderate Covid-19 who were at high risk of progression to severe disease.
Preliminary results indicate that Paxlovid reduced the risk of hospitalization or death compared to placebo when treatment was given within 3 to 5 days of onset of symptoms. The CHMP will also review data on the quality and safety of the medicine.
“Although it is expected the beginning of a more complete ongoing review ahead of a possible application for a marketing authorization, this current revision will provide EU-wide recommendations 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 “, explains the EMA.
The opinion on the use of the Merck pill
EMA’s Committee for Human Medicines (CHMP) has issued an opinion on the use of Lagevrio (the Merck pill, also known as molnupiravir or MK 4482) for treatment against Covid-19. “The drug, which is currently not 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 a severe form,” explains the EMA.
“Lagevrio must be administered as soon as possible after the diagnosis of Covid-19 and within 5 days of the onset of symptoms. The medicine, available in capsules, must be taken twice a day for 5 days”, reads the indications.
Ema has issued the warning to support national authorities who may decide on a possible early use of the medicine before marketing authorization, for example in emergency settings, in light of the increase in infection rates and of deaths due to Covid across the EU.
“Lagevrio is not recommended during pregnancy and in women who may become pregnant and who are not using effective contraception. Women who can become pregnant must use effective contraception during treatment and for 4 days after the last dose of Lagevrio.. Breastfeeding should be stopped during treatment and for 4 days after treatment, “recommends the European agency.
Test data shows that Lagevrio, given at a dose of 800 mg twice a day, reduced the risk of hospitalization and death when treatment was started within 5 days of the onset of symptoms.
Approximately one month after starting treatment, 7.3% of patients (28 out of 385) who took Lagevrio compared to 14.1% (53 out of 377) of patients who took placebo were hospitalized or were deceased; none of the patients in the Lagevrio group died compared to eight patients in the placebo group.