Good news to all clinicians and patients involved in the fight against Covid-19 infection: in the last months, two new antiviral agents developed by Pfizer and Merck, were almost simultaneously approved by the FDA and the EMA, adding new hopes for a successful fight against the pandemic and for the benefit of all infected patients.
Pfizer announced that a positive recommendation was given to issue a conditional marketing authorization (CMA) of Paxlovid™ (nirmatrelvir tablets and ritonavir tablets) for the treatment of Covid-19 in adults who do not require supplemental oxygen and who are at increased risk for progressing to severe Covid-19. This announcement came after positive opinions were expressed by the FDA and the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency.
“This expression of confidence in Paxlovid comes at a critical moment as Europe addresses the ongoing challenges of the pandemic and as infection rates are on the rise in many countries across the globe,” said Albert Bourla, Chairman and Chief Executive Officer, Pfizer. “We are proud to have a strong manufacturing footprint in Europe, which will help support the production of up to 120 million courses of Paxlovid globally. Pending conditional marketing authorization from the European Commission, we will continue working closely with EU Member State governments to ensure this important treatment can be made available to patients across Europe as quickly as possible.”
Molnupiravir by Merck is a product that the FDA and the EMA are allowing to be given for emergency use to treat Covid-19. It is used by adults 18 years of age and older who have recently tested positive for coronavirus, have had mild to moderate symptoms for no more than 5 days, and are not hospitalized. To receive this product patients must also be at high risk for Covid-19 complications due to older age, obesity, or ongoing medical conditions (such as lung or heart disease or diabetes, among others). Molnupiravir works by preventing the growth of the virus that causes Covid-19.
More information about molnupiravir is available from the FDA Fact Sheet for Patients, Parents, and Caregivers for Emergency Use, and in the EMA assessment report. There is limited information about how safe and effective molnupiravir is for treating Covid-19. Study results show that molnupiravir may help people who have recently tested positive for coronavirus stay out of the hospital. This product is not for use by people who are hospitalized due to Covid-19. Information on molnupiravir is continuously updated based on new emerging data, which is evolving and subject to reassessment. Clinicians should be aware of these considerations in their review of clinical data on molnupiravir.
For more details, please go to https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-authorizes-first-oral-antiviral-treatment-covid-19
and to
and to
https://www.webmd.com/drugs/2/drug-183164/molnupiravir-oral/details
and to
https://www.ema.europa.eu/en/news/ema-issues-advice-use-lagevrio-molnupiravir-treatment-covid-19
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