Swissmedic approves Paxlovid for COVID-19 patients

Paxlovid from Pfizer AG granted temporary authorisation in Switzerland


Swissmedic has granted temporary authorisation for two years to Paxlovid, the prescription of which was already permitted in Switzerland under COVID-19 Ordinance 3. Paxlovid comprises two products with the active substances nirmatrelvir [PF-07321332] and ritonavir. It is taken in tablet form and can be used to treat coronavirus disease.

Paxlovid is used in adults who do not require supplemental oxygen or hospitalisation due to COVID-19 and are at increased risk of developing a severe form of COVID-19.

Treatment should be implemented as soon as possible after diagnosis and within five days of onset of symptoms. Treatment lasts for five days.

Nirmatrelvir is a novel active substance which inhibits a SARS-CoV-2 enzyme that plays an important role in the replication of the virus. The second substance, ritonavir, is added to ensure that nirmatrelvir is broken down more slowly in the liver and its antiviral efficacy lasts for longer. It has been used in HIV therapy for more than 20 years.

Swissmedic reviewed the application for authorisation from 14 January 2022 onwards in a rolling submission. This involved the continual collection and submission of data by Pfizer AG. No specific patient data on efficacy against the Omicron variant were submitted. However, the laboratory data indicate that Paxlovid is effective in vitro against the Omicron variant.