Pharmaceutical company Pfizer has submitted an authorisation application to Swissmedic for the medicinal product Paxlovid for the treatment of COVID-19. This medicinal product has two synthetic active substances in separate tablets.
New oral medicinal product Paxlovid (active substances nirmatrelvir/ritonavir) for the treatment of COVID-19 in rolling review process
Nirmatrelvir is a novel active substance which inhibits a SARS-CoV-2 enzyme (SARS-CoV-2 protease) that plays an important role in the replication of the virus. The second substance, ritonavir, is added to ensure that nirmatrelvir is not broken down too quickly in the liver and its antiviral efficacy lasts for longer. Ritonavir is a known active substance that has been successfully used in HIV treatment for more than 20 years.
Under the rolling review process, applicants do not have to present a complete dossier when they first submit their application. Initial data packages from preclinical and clinical studies and on quality have been submitted. Further data will follow on a continuous basis as soon as they are available. This accelerates the review process while at the same time preserving the same level of careful checking of all requirements relating to safety, efficacy and quality.